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CompletedNCT03408392Updated Feb 25, 2020Results posted

Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions

A Phase 1 interventional study of Test formulation A and Reference formulation B in Infections, Bacterial, sponsored by GlaxoSmithKline. Completed at 1 site in South Africa. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is open-label, randomized two-way cross-over study to determine if cefixime 200 mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200 mg/5 mL suspension reference formulation. Study will be conducted in 28 healthy adult subjects under fasting conditions. There will be two treatment periods and each subject will participate in both periods. The washout period between both treatment periods will be 7-14 days. Subjects will be randomized to either of treatment sequences of reference followed by test or test followed by reference to receive a single dose of test or reference formulation on Day 1 in each treatment period. The study will last for 5 to 7 weeks.

02

Conditions studied

  • Infections, Bacterial

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Keywords

  • Single dose
  • Oral suspension
  • Bioequivalence
  • Cefixime
  • Two-way crossover
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Subject must be healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included at investigator discretion in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Subject with a body weight 50 kilogram (kg) and body mass index (BMI) within the range 19-30 kilogram per meter square (kg/m\^2) (inclusive).
  • A healthy male subject must agree to use contraception during the treatment period and for at least 5 days after the last dose of study treatment and refrain from donating sperm during this period.
  • A female subject is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
  • A subject should be capable of giving signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Subject with history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
  • Subjects with any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
  • Subject with abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.
  • Subject with abnormal blood pressure (BP) as determined by the investigator.
  • Subject with lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
  • Subject who had breast cancer within the past 10 years.
  • ALT >1.5 times upper limit of normal (ULN).
  • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
  • Subject with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Subject with history of colitis
  • Subject with history of cephalosporin induced hemolytic anemia.
  • QT interval corrected for heart rate according to Bazett's formula (QTcB) >450 milliseconds (msec). Subjects with a known risk of QT prolongation will be excluded.
  • Past or intended use of over-the-counter or prescription medication including herbal medications, within 14 days prior to dosing unless in the opinion of the investigator and sponsor, the medication will not interfere with the study.
  • Participation in the study would result in loss of blood or blood products in excess of 500 mL within 90 days.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Current enrolment or past participation within the last 90 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.
  • Presence of Hepatitis B surface antigen (HBsAg) at screening. Positive Hepatitis C antibody test result at screening. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.
  • Positive pre-study drug/alcohol screen.
  • Positive human immunodeficiency virus (HIV) antibody test.
  • Regular use of known drugs of abuse.
  • Subjects with regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
  • Subjects with urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Subjects who are sensitive to heparin or heparin-induced thrombocytopenia.
  • Subjects with known sensitivity to any drugs from the class of cephalosporin, or components thereof.
  • Subjects with known sensitivity to any drugs from the class of penicillin, or components thereof.
  • Subjects with known sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Test followed by Reference Formulation

    Subjects will be randomized to receive single dose of Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 1 and Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.

    Drug: Test formulation A · Drug: Reference formulation B

  • Experimental
    Reference followed by Test Formulation

    Subjects will be randomized to receive single dose of Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 1 and Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.

    Drug: Test formulation A · Drug: Reference formulation B

Interventions

  • DrugTest formulation A

    Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor.

  • DrugReference formulation B

    Reference formulation will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a strawberry flavor and odor.

05

What researchers measure

Primary outcomes

  1. Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime

    Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.

    Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

  2. Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime

    Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

    Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

Secondary outcomes

  1. Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime

    Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

    Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

  2. Time of Occurrence of Cmax (Tmax) for Cefixime

    Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.

    Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

  3. Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime

    Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

    Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

  4. Terminal Phase Half-life (T1/2) for Cefixime

    Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

    Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period

  5. Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.

    Time frame: Up to Day 16 in each treatment period

  6. Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.

    Time frame: Day -1 and Day 2 of each treatment period

  7. Blood Urea Nitrogen (BUN) at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.

    Time frame: Day -1 and Day 2 of each treatment period

  8. Calcium, Glucose, Potassium and Sodium at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.

    Time frame: Day -1 and Day 2 of each treatment period

  9. Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.

    Time frame: Day -1 and Day 2 of each treatment period

  10. Total Protein at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.

    Time frame: Day -1 and Day 2 of each treatment period

  11. Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.

    Time frame: Day -1 and Day 2 of each treatment period

  12. Mean Corpuscular Volume (MCV) at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.

    Time frame: Day -1 and Day 2 of each treatment period

  13. Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.

    Time frame: Day -1 and Day 2 of each treatment period

  14. Erythrocyte Count at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.

    Time frame: Day -1 and Day 2 of each treatment period

  15. Hematocrit at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.

    Time frame: Day -1 and Day 2 of each treatment period

  16. Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.

    Time frame: Day -1 and Day 2 of each treatment period

  17. Percent Reticulocytes at Indicated Time-points

    Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.

    Time frame: Day -1 and Day 2 of each treatment period

  18. Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis

    Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.

    Time frame: Day -1 and Day 2 of each treatment period

  19. Respiratory Rate at Indicated Time-points

    Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

    Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

  20. Pulse Rate at Indicated Time-points

    Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

    Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

  21. Body Temperature at Indicated Time-points

    Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

    Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

  22. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points

    Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

    Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period

06

Results

Posted Mar 22, 2019

Participant flow

This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of SKF101804 Cefixime 200 milligram (mg)/5 milliliter (mL) suspension versus Cefixime 200 mg/5 mL suspension reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.

Treatment Period 1 (16 Days)
Participant flow — Treatment Period 1 (16 Days)
MilestoneSKF101804 Cefixime Followed by Cefixime Reference FormulationCefixime Reference Formulation Followed by SKF101804 Cefixime
Started1414
Completed1414
Not completed00
Wash-out Period (14 Days)
Participant flow — Wash-out Period (14 Days)
MilestoneSKF101804 Cefixime Followed by Cefixime Reference FormulationCefixime Reference Formulation Followed by SKF101804 Cefixime
Started1414
Completed1414
Not completed00
Treatment Period 2 (16 Days)
Participant flow — Treatment Period 2 (16 Days)
MilestoneSKF101804 Cefixime Followed by Cefixime Reference FormulationCefixime Reference Formulation Followed by SKF101804 Cefixime
Started1414
Completed1414
Not completed00

Outcome measures

PrimaryArea Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.

Time frame:
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Reported as:
Geometric mean · Hour*nanogram per milliliter
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime
Hour*nanogram per milliliterSKF101804 CefiximeCefixime Reference Formulation
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime20000 ± 32.919000 ± 34.3
Statistical analysis
  • SKF101804 Cefixime vs Cefixime Reference Formulation · Percentage ratio: 105.38 · 90% CI 96.11 to 115.54
PrimaryMaximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

Time frame:
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Reported as:
Geometric mean · Nanogram per milliliter
Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime
Nanogram per milliliterSKF101804 CefiximeCefixime Reference Formulation
Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime2670 ± 29.42640 ± 30.5
Statistical analysis
  • SKF101804 Cefixime vs Cefixime Reference Formulation · Percentage ratio: 101.14 · 90% CI 93.37 to 109.55
SecondaryArea Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

Time frame:
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Reported as:
Geometric mean · Hour*nanogram per milliliter
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime
Hour*nanogram per milliliterSKF101804 CefiximeCefixime Reference Formulation
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime20700 ± 31.819700 ± 33.3
Statistical analysis
  • SKF101804 Cefixime vs Cefixime Reference Formulation · Percentage ratio: 105.14 · 90% CI 96.31 to 114.78
SecondaryTime of Occurrence of Cmax (Tmax) for Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.

Time frame:
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Reported as:
Median · Hours
Time of Occurrence of Cmax (Tmax) for Cefixime
HoursSKF101804 CefiximeCefixime Reference Formulation
Time of Occurrence of Cmax (Tmax) for Cefixime4.005 (2.50 to 6.02)4.005 (2.02 to 4.51)
SecondaryPercentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

Time frame:
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Reported as:
Geometric mean · Percentage of AUCex
Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime
Percentage of AUCexSKF101804 CefiximeCefixime Reference Formulation
Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime3.24 ± 51.43.32 ± 67.8
SecondaryTerminal Phase Half-life (T1/2) for Cefixime

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.

Time frame:
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Reported as:
Geometric mean · Hours
Terminal Phase Half-life (T1/2) for Cefixime
HoursSKF101804 CefiximeCefixime Reference Formulation
Terminal Phase Half-life (T1/2) for Cefixime3.18 ± 15.03.13 ± 14.7
SecondaryNumber of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.

Time frame:
Up to Day 16 in each treatment period
Reported as:
Count of participants · Participants
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
ParticipantsSKF101804 CefiximeCefixime Reference Formulation
Non-serious AEs00
SAEs00
SecondaryAlanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Units per liter
Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points
Units per literSKF101804 CefiximeCefixime Reference Formulation
ALT; Period 1; Day -1, 24 Hours Pre-dose16.6 ± 10.2315.6 ± 5.67
ALT; Period 1; Day 2, 24 Hours Post-dose13.6 ± 7.0914.0 ± 5.76
ALT; Period 2; Day -1, 24 Hours Pre-dose16.4 ± 8.9816.7 ± 9.15
ALT; Period 2; Day 2, 24 Hours Post-dose14.1 ± 7.0714.9 ± 7.68
ALP; Period 1; Day -1, 24 Hours Pre-dose80.4 ± 12.8574.8 ± 18.25
ALP; Period 1; Day 2, 24 Hours Post-dose75.5 ± 14.2767.1 ± 15.23
ALP; Period 2; Day -1, 24 Hours Pre-dose72.4 ± 17.5880.9 ± 15.81
ALP; Period 2; Day 2, 24 Hours Post-dose69.7 ± 16.9676.9 ± 15.13
AST; Period 1; Day -1, 24 Hours Pre-dose20.9 ± 4.4020.6 ± 4.22
AST; Period 1; Day 2, 24 Hours Post-dose16.7 ± 2.6417.1 ± 3.45
AST; Period 2; Day -1, 24 Hours Pre-dose20.5 ± 6.0019.9 ± 4.57
AST; Period 2; Day 2, 24 Hours Post-dose16.8 ± 3.7517.8 ± 4.08
SecondaryBlood Urea Nitrogen (BUN) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Milligrams per deciliter
Blood Urea Nitrogen (BUN) at Indicated Time-points
Milligrams per deciliterSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day -1, 24 Hours Pre-dose10.354 ± 1.97210.300 ± 4.120
Period 1; Day 2, 24 Hours Post-dose12.945 ± 2.34912.258 ± 2.664
Period 2; Day -1, 24 Hours Pre-dose10.841 ± 3.57111.844 ± 2.017
Period 2; Day 2, 24 Hours Post-dose12.041 ± 2.16612.796 ± 1.599
SecondaryCalcium, Glucose, Potassium and Sodium at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Millimoles per liter
Calcium, Glucose, Potassium and Sodium at Indicated Time-points
Millimoles per literSKF101804 CefiximeCefixime Reference Formulation
Calcium;Period 1;Day -1, 24 Hours Pre-dose2.393 ± 0.0592.399 ± 0.134
Calcium;Period 1;Day 2, 24 Hours Post-dose2.308 ± 0.0682.304 ± 0.076
Calcium;Period 2;Day -1, 24 Hours Pre-dose2.364 ± 0.0992.376 ± 0.060
Calcium;Period 2;Day 2, 24 Hours Post-dose2.351 ± 0.0872.378 ± 0.081
Glucose;Period 1;Day -1, 24 Hours Pre-dose4.684 ± 0.2564.616 ± 0.267
Glucose;Period 1;Day 2, 24 Hours Post-dose4.728 ± 0.2294.676 ± 0.295
Glucose;Period 2;Day -1, 24 Hours Pre-dose4.521 ± 0.3474.571 ± 0.404
Glucose;Period 2;Day 2, 24 Hours Post-dose4.851 ± 0.3754.812 ± 0.278
Sodium;Period 1;Day -1, 24 Hours Pre-dose143.86 ± 1.460145.00 ± 1.414
Sodium;Period 1;Day 2, 24 Hours Post-dose141.07 ± 1.439141.43 ± 1.604
Sodium;Period 2;Day -1, 24 Hours Pre-dose141.21 ± 1.251141.50 ± 1.912
Sodium;Period 2;Day 2, 24 Hours Post-dose139.43 ± 1.089139.64 ± 1.550
Potassium;Period1;Day -1, 24 Hours Pre-dose4.634 ± 0.4574.404 ± 0.316
Potassium;Period1;Day 2, 24 Hours Post-dose4.522 ± 0.4444.286 ± 0.206
Potassium;Period 2;Day -1, 24 Hours Pre-dose4.371 ± 0.2204.521 ± 0.346
Potassium;Period 2;Day 2, 24 Hours Post-dose4.269 ± 0.3344.555 ± 0.402
SecondaryTotal Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Micromoles per liter
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Micromoles per literSKF101804 CefiximeCefixime Reference Formulation
Creat; Period 1; Day -1, 24 Hours Pre-dose82.4 ± 15.2983.4 ± 15.45
Creat; Period 1; Day 2, 24 Hours Post-dose79.9 ± 12.0085.9 ± 15.59
Creat; Period 2; Day -1, 24 Hours Pre-dose81.1 ± 14.3178.5 ± 14.21
Creat; Period 2; Day 2, 24 Hours Post-dose83.9 ± 15.3378.4 ± 12.71
Total bil; Period1;Day -1, 24 Hours Pre-dose10.14 ± 4.63310.99 ± 6.235
Total bil; Period1;Day 2, 24 Hours Post-dose6.83 ± 3.0048.10 ± 6.191
Total bil; Period2;Day -1, 24 Hours Pre-dose9.90 ± 7.2058.22 ± 3.516
Total bil; Period2;Day 2, 24 Hours Post-dose6.47 ± 3.7496.16 ± 2.843
Direct bil; Period1;Day -1, 24 Hours Pre-dose3.68 ± 1.2944.01 ± 1.794
Direct bil; Period1;Day 2, 24 Hours Post-dose2.65 ± 0.9592.93 ± 1.630
Direct bil; Period2;Day -1, 24 Hours Pre-dose3.58 ± 1.9453.12 ± 1.057
Direct bil; Period2;Day 2, 24 Hours Post-dose2.55 ± 1.1492.49 ± 0.972
SecondaryTotal Protein at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Grams per liter
Total Protein at Indicated Time-points
Grams per literSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day -1, 24 Hours Pre-dose74.34 ± 3.35474.77 ± 4.725
Period 1; Day 2, 24 Hours Post-dose67.90 ± 3.29567.97 ± 2.635
Period 2; Day -1, 24 Hours Pre-dose73.76 ± 3.99572.57 ± 3.886
Period 2; Day 2, 24 Hours Post-dose67.64 ± 3.18167.89 ± 4.211
SecondaryPlatelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · 10^9 cells per liter
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
10^9 cells per literSKF101804 CefiximeCefixime Reference Formulation
Basophil; Period 1;Day -1, 24 Hours Pre-dose0.023 ± 0.0170.022 ± 0.013
Basophil; Period 1;Day 2, 24 Hours Post-dose0.024 ± 0.0120.025 ± 0.011
Basophil; Period 2;Day -1, 24 Hours Pre-dose0.026 ± 0.0120.029 ± 0.025
Basophil; Period 2;Day 2, 24 Hours Post-dose0.024 ± 0.0120.022 ± 0.026
Eosinophil; Period 1;Day-1, 24 Hours Pre-dose0.136 ± 0.1300.182 ± 0.157
Eosinophil; Period 1;Day 2, 24 Hours Post-dose0.146 ± 0.1300.204 ± 0.199
Eosinophil; Period 2; Day -1, 24 Hours Pre-dose0.231 ± 0.2300.139 ± 0.144
Eosinophil; Period 2; Day 2, 24 Hours Post-dose0.253 ± 0.2450.156 ± 0.182
Leucocyte; Period 1;Day-1,24 Hours Pre-dose5.458 ± 1.6435.752 ± 0.907
Leucocyte; Period 1;Day 2,24 Hours Post-dose5.369 ± 1.5355.394 ± 1.019
Leucocyte; Period 2;Day -1,24 Hours Pre-dose5.736 ± 1.1685.463 ± 1.388
Leucocyte; Period 2;Day 2,24 Hours Post-dose5.887 ± 1.2165.477 ± 1.571
Lymphocyte; Period 1;Day -1,24 Hours Pre-dose2.127 ± 0.5622.154 ± 0.493
Lymphocyte; Period 1;Day 2,24 Hours Post-dose1.916 ± 0.4532.039 ± 0.459
Lymphocyte; Period 2;Day -1,24 Hours Pre-dose2.328 ± 0.5732.141 ± 0.409
Lymphocyte; Period 2;Day 2,24 Hours Post-dose2.186 ± 0.4311.956 ± 0.486
Monocytes; Period 1;Day -1,24 Hours Pre-dose0.480 ± 0.1230.470 ± 0.127
Monocytes; Period 1;Day 2,24 Hours Post-dose0.464 ± 0.1420.459 ± 0.125
Monocytes; Period 2;Day -1,24 Hours Pre-dose0.461 ± 0.1460.497 ± 0.126
Monocytes; Period 2;Day 2,24 Hours Post-dose0.475 ± 0.1600.457 ± 0.122
Neutrophils;Period 1;Day -1,24 Hours Pre-dose2.692 ± 1.2932.924 ± 0.706
Neutrophils;Period 1;Day 2,24 Hours Post-dose2.820 ± 1.2892.667 ± 0.667
Neutrophils;Period 2;Day -1,24 Hours Pre-dose2.691 ± 0.6972.657 ± 1.162
Neutrophils;Period 2;Day 2,24 Hours Post-dose2.949 ± 0.8482.885 ± 1.204
Platelet; Period 1;Day -1,24 Hours Pre-dose288.9 ± 61.98264.4 ± 60.63
Platelet; Period 1;Day 2,24 Hours Post-dose281.2 ± 65.74244.5 ± 64.60
Platelet; Period 2;Day -1,24 Hours Pre-dose264.6 ± 61.65289.6 ± 72.29
Platelet; Period 2;Day 2,24 Hours Post-dose245.0 ± 56.04274.2 ± 68.61
SecondaryMean Corpuscular Volume (MCV) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Femtoliter
Mean Corpuscular Volume (MCV) at Indicated Time-points
FemtoliterSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day -1, 24 Hours Pre-dose85.73 ± 2.83484.86 ± 4.946
Period 1; Day 2, 24 Hours Post-dose85.30 ± 2.79684.50 ± 4.895
Period 2; Day -1, 24 Hours Pre-dose84.83 ± 4.97585.97 ± 2.903
Period 2; Day 2, 24 Hours Post-dose84.46 ± 4.87885.41 ± 2.847
SecondaryMean Corpuscular Hemoglobin (MCH) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Picogram
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
PicogramSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day -1, 24 Hours Pre-dose29.58 ± 1.21229.44 ± 2.140
Period 1; Day 2, 24 Hours Post-dose29.75 ± 1.29529.51 ± 2.190
Period 2; Day -1, 24 Hours Pre-dose29.40 ± 2.24229.68 ± 1.207
Period 2; Day 2, 24 Hours Post-dose29.54 ± 2.11229.75 ± 1.320
SecondaryErythrocyte Count at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · 10^12 cells per liter
Erythrocyte Count at Indicated Time-points
10^12 cells per literSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day -1, 24 Hours Pre-dose5.104 ± 0.4515.020 ± 0.480
Period 1; Day 2, 24 Hours Post-dose4.952 ± 0.3874.871 ± 0.424
Period 2; Day -1, 24 Hours Pre-dose5.006 ± 0.3664.971 ± 0.473
Period 2; Day 2, 24 Hours Post-dose4.838 ± 0.4334.906 ± 0.494
SecondaryHematocrit at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Proportion of red blood cells in blood
Hematocrit at Indicated Time-points
Proportion of red blood cells in bloodSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day -1, 24 Hours Pre-dose0.437 ± 0.0360.426 ± 0.043
Period 1; Day 2, 24 Hours Post-dose0.422 ± 0.0330.411 ± 0.038
Period 2; Day -1, 24 Hours Pre-dose0.424 ± 0.0290.427 ± 0.040
Period 2; Day 2, 24 Hours Post-dose0.408 ± 0.0360.419 ± 0.041
SecondaryMean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Grams per deciliter
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Grams per deciliterSKF101804 CefiximeCefixime Reference Formulation
MCHC; Period 1; Day -1, 24 Hours Pre-dose34.52 ± 1.03034.68 ± 0.957
MCHC; Period 1; Day 2, 24 Hours Post-dose34.88 ± 1.08434.89 ± 1.100
MCHC; Period 2; Day -1, 24 Hours Pre-dose34.64 ± 1.10034.54 ± 0.880
MCHC; Period 2; Day 2, 24 Hours Post-dose34.95 ± 1.09734.82 ± 1.062
Hb; Period 1;Day -1, 24 Hours Pre-dose15.11 ± 1.55414.79 ± 1.833
Hb; Period 1;Day 2, 24 Hours Post-dose14.74 ± 1.39114.38 ± 1.623
Hb; Period 2;Day -1, 24 Hours Pre-dose14.70 ± 1.38114.76 ± 1.591
Hb; Period 2;Day 2, 24 Hours Post-dose14.29 ± 1.57814.60 ± 1.708
SecondaryPercent Reticulocytes at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Mean · Percentage of reticulocytes
Percent Reticulocytes at Indicated Time-points
Percentage of reticulocytesSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day -1, 24 Hours Pre-dose1.786 ± 0.3611.700 ± 0.346
Period 1; Day 2, 24 Hours Post-dose1.757 ± 0.3841.571 ± 0.297
Period 2; Day -1, 24 Hours Pre-dose1.729 ± 0.3971.886 ± 0.335
Period 2; Day 2, 24 Hours Post-dose2.350 ± 2.1761.743 ± 0.361
SecondaryNumber of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis

Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.

Time frame:
Day -1 and Day 2 of each treatment period
Reported as:
Count of participants · Participants
Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis
ParticipantsSKF101804 CefiximeCefixime Reference Formulation
Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis00
SecondaryRespiratory Rate at Indicated Time-points

Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Time frame:
Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Reported as:
Mean · Breaths per minute
Respiratory Rate at Indicated Time-points
Breaths per minuteSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day 1, 1.5 Hours Pre-dose15.0 ± 1.1115.7 ± 0.73
Period 1; Day 1, 2 Hours Post-dose17.3 ± 2.0217.0 ± 2.69
Period 1; Day 1, 4 Hours Post-dose15.5 ± 2.1014.2 ± 1.25
Period 1; Day 1, 6 Hours Post-dose15.0 ± 2.0014.8 ± 0.97
Period 1; Day 2, 24 Hours Post-dose15.9 ± 2.1416.1 ± 2.95
Period 2; Day 1, 1.5 Hours Pre-dose15.8 ± 1.1915.6 ± 0.74
Period 2; Day 1, 2 Hours Post-dose18.4 ± 1.6518.2 ± 1.72
Period 2; Day 1, 4 Hours Post-dose16.7 ± 3.1018.4 ± 1.65
Period 2; Day 1, 6 Hours Post-dose17.9 ± 1.4619.0 ± 1.04
Period 2; Day 2, 24 Hours Post-dose16.2 ± 1.2516.0 ± 2.22
SecondaryPulse Rate at Indicated Time-points

Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Time frame:
Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Reported as:
Mean · Beats per minute
Pulse Rate at Indicated Time-points
Beats per minuteSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day 1, 1.5 Hours Pre-dose67.0 ± 7.9558.1 ± 8.76
Period 1; Day 1, 2 Hours Post-dose61.0 ± 8.1755.1 ± 8.32
Period 1; Day 1, 4 Hours Post-dose61.9 ± 7.4455.6 ± 7.49
Period 1; Day 1, 6 Hours Post-dose75.0 ± 8.7467.2 ± 12.97
Period 1; Day 2, 24 Hours Post-dose66.5 ± 10.2654.3 ± 7.22
Period 2; Day 1, 1.5 Hours Pre-dose57.9 ± 9.0865.1 ± 6.85
Period 2; Day 1, 2 Hours Post-dose54.1 ± 8.8863.1 ± 8.87
Period 2; Day 1, 4 Hours Post-dose56.6 ± 8.6762.8 ± 7.92
Period 2; Day 1, 6 Hours Post-dose68.5 ± 14.0975.1 ± 8.82
Period 2; Day 2, 24 Hours Post-dose59.2 ± 7.5967.1 ± 8.62
SecondaryBody Temperature at Indicated Time-points

Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Time frame:
Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Reported as:
Mean · Degree Celsius
Body Temperature at Indicated Time-points
Degree CelsiusSKF101804 CefiximeCefixime Reference Formulation
Period 1; Day 1, 1.5 Hours Pre-dose36.19 ± 0.30536.27 ± 0.336
Period 1; Day 1, 2 Hours Post-dose36.38 ± 0.33336.23 ± 0.261
Period 1; Day 1, 4 Hours Post-dose36.48 ± 0.33636.59 ± 0.352
Period 1; Day 1, 6 Hours Post-dose36.64 ± 0.30336.79 ± 0.202
Period 1; Day 2, 24 Hours Post-dose36.29 ± 0.31736.24 ± 0.365
Period 2; Day 1, 1.5 Hours Pre-dose36.28 ± 0.37236.29 ± 0.317
Period 2; Day 1, 2 Hours Post-dose36.51 ± 0.40036.42 ± 0.404
Period 2; Day 1, 4 Hours Post-dose36.58 ± 0.34736.51 ± 0.243
Period 2; Day 1, 6 Hours Post-dose36.10 ± 0.42136.63 ± 0.300
Period 2; Day 2, 24 Hours Post-dose36.30 ± 0.32136.11 ± 0.434
SecondarySystolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points

Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.

Time frame:
Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Reported as:
Mean · Millimeters of mercury
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
Millimeters of mercurySKF101804 CefiximeCefixime Reference Formulation
SBP, Period 1; Day 1, 1.5 Hours Pre-dose110.6 ± 8.22110.9 ± 6.39
SBP, Period 1; Day 1, 2 Hours Post-dose113.4 ± 7.30111.3 ± 8.68
SBP, Period 1; Day 1, 4 Hours Post-dose112.3 ± 8.39112.1 ± 4.25
SBP, Period 1; Day 1, 6 Hours Post-dose111.6 ± 7.17108.6 ± 6.46
SBP, Period 1; Day 2, 24 Hours Post-dose110.9 ± 6.86115.4 ± 7.00
SBP, Period 2; Day 1, 1.5 Hours Pre-dose110.4 ± 3.97111.2 ± 10.09
SBP, Period 2; Day 1, 2 Hours Post-dose113.1 ± 6.24112.7 ± 10.94
SBP, Period 2; Day 1, 4 Hours Post-dose112.6 ± 8.53111.1 ± 9.79
SBP, Period 2; Day 1, 6 Hours Post-dose109.6 ± 7.14109.5 ± 8.98
SBP, Period 2; Day 2, 24 Hours Post-dose113.1 ± 6.24113.6 ± 9.05
DBP, Period 1; Day 1, 1.5 Hours Pre-dose62.9 ± 6.5964.1 ± 7.76
DBP, Period 1; Day 1, 2 Hours Post-dose62.9 ± 7.6960.9 ± 6.38
DBP, Period 1; Day 1, 4 Hours Post-dose62.5 ± 5.4363.3 ± 6.94
DBP, Period 1; Day 1, 6 Hours Post-dose59.3 ± 3.8959.6 ± 5.09
DBP, Period 1; Day 2, 24 Hours Post-dose63.0 ± 6.8066.2 ± 7.65
DBP, Period 2; Day 1, 1.5 Hours Pre-dose111.2 ± 10.0961.8 ± 7.20
DBP, Period 2; Day 1, 2 Hours Post-dose66.2 ± 7.6563.1 ± 9.12
DBP, Period 2; Day 1, 4 Hours Post-dose63.5 ± 8.5562.6 ± 8.21
DBP, Period 2; Day 1, 6 Hours Post-dose59.4 ± 4.9760.2 ± 7.79
DBP, Period 2; Day 2, 24 Hours Post-dose63.9 ± 7.4167.7 ± 7.90

Adverse events

Collected over Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to Day 16 in each treatment period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SKF101804 Cefixime0/28 (0%)0/28 (0%)0/28 (0%)
Cefixime Reference Formulation0/28 (0%)0/28 (0%)0/28 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)All Participants
Mean28.9 ± 7.90
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female7
Male21
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)All Participants
Mixed Race3
White/Caucasian/European Heritage4
Black or African American21
07

Study locations

1 site
  • GSK Investigational Site
    Bloemfontein, Free State 9300, South Africa
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 13, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Icf, Csr

09

Registry details

Key details

Study ID
NCT03408392
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Feb 6, 2018
Primary completion
Mar 13, 2018
Completion
Mar 13, 2018
Results posted
Mar 22, 2019
Last update
Feb 25, 2020

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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