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WithdrawnNCT04878315Updated Jan 27, 2023

Bioequivalence Study Between Capoten Versus Captopril Reference Product in Healthy Adult Participants Under Fasting Conditions

A Phase 1 interventional study of Capoten and Captopril in Healthy Volunteers, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-27.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Internal sponsor decision to terminate project prematurely based on a waiver granted by Egypt EDA (Egyptian drug authority). No subjects were enrolled.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This is a bioequivalence study to compare Capoten (test product [T]) versus captopril (reference product [R]) produced by Mylan Pharmaceuticals Spain, in healthy adult participants under fasting condition. Capoten is the registered trademark of SmithKline Beecham Egypt.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Bioequivalence
  • Capoten
  • Captopril
  • Healthy Volunteers
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 to 50 years of age inclusive
  • Participant does not have a known allergy to the drug under investigation, any of its ingredients or any other related drugs.
  • Normal vital signs after up to 10 minutes resting in supine position or 2 minutes in sitting position: 100 millimeter of mercury (mmHg) =\< systolic blood pressure (SBP) \<130 mmHg; 70 mmHg =\< diastolic blood pressure (DBP) \<90 mmHg; 60 beats per minute (bpm) =\< Pulse rate (HR) =\< 100 bpm.
  • Normal standard 12-lead ECG after 10 minutes resting in supine position in the following ranges; 120 milliseconds (ms)\<PR\<220 ms, QRS\<120 ms, corrected QT interval (QTc)=\<450 ms, and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
  • Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participants; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) should not exceed 1.25 times the upper laboratory norm, and total bilirubin should not exceed the upper laboratory normal (Laboratory tests are performed not longer than two weeks before the initiation of the clinical study).
  • Body weight on 45 kilogram (kg) or more and body mass index (BMI) within the range 18.5-30 kilogram per meter square (kg/m\^2) (inclusive).
  • Healthy Adult, Male and Female (woman of non-childbearing potential [WONCBP]); a) Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 30 days after the last dose of the study drug. Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed in the protocol; Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant, agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. Contraceptive use by Men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female Participants: is eligible to participate if: Is a WONCBP as defined in the protocol. Additional requirements for testing are listed in the protocol. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Female participants must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
  • Capable of giving signed informed consent as described in the protocol.

Exclusion criteria

Exclusion Criteria:

  • Any history or presence of clinically relevant cardiovascular including history of hypotension and orthostatic hypotension, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular or infectious disease, or signs of acute illness, lactose intolerance.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
  • Blood donation, any volume, within 2 months.
  • Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure >=30 mmHg within 3 minutes when changing from supine to standing position.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the investigational medicinal product (IMP) formulation or allergic disease diagnosed and treated by a physician.
  • History of drug or alcohol abuse. History of regular alcohol consumption within one year of the study defined as: an average weekly intake of >14 drinks. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
  • Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases [more than 4 cups or glasses (average 100 mL) per day].
  • Use of any prescribed medication, over the counter (OTC) medicines or medicinal products during the last two weeks preceding the first dosing and until discharge from the study.
  • Participation in a bioequivalence study or in a clinical study within the last 60 days (2 months) before first study drug administration.
  • Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
  • Positive result on urine drug screen (amphetamines/ methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • Participant who has results of laboratory tests which are outside the normal range or hemoglobin (Hb) or red blood cells (RBC) indices (mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH] and mean corpuscular hemoglobin concentration [MCHC]) with deviation outside 5% of the reference range at screening. (Laboratory tests are performed not longer than two weeks before the initiation of the clinical study).
  • Participants who have been on a specific/special diet during the 4 weeks before screening and who cannot agree to eat the set clinical food menu during the study.
  • Difficulty in swallowing tablets.
  • Participants that have a current active Coronavirus disease 2019 (COVID-19) infection, either laboratory confirmed or according to the investigator's medical judgement.
  • Participants known to be in contact with active COVID-19 positive individuals within the past 14 days.
05

Study design

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

Study arms

  • Experimental
    Treatment sequence TRR

    Participants will receive Capoten (T) in period 1 followed by Captopril (R) in period 2 followed by Captopril (R) in period 3.

    Drug: Capoten · Drug: Captopril

  • Experimental
    Treatment sequence RTR

    Participants will receive Captopril (R) in period 1 followed by Capoten (T) in period 2 followed by Captopril (R) in period 3.

    Drug: Capoten · Drug: Captopril

  • Experimental
    Treatment sequence RRT

    Participants will receive Captopril (R) in period 1 followed by Captopril (R) in period 2 followed by Capoten (T) in period 3.

    Drug: Capoten · Drug: Captopril

Interventions

  • DrugCapoten

    Capoten will be administered per the treatment sequence

  • DrugCaptopril

    Captopril will be administered per the treatment sequence

06

What researchers measure

Primary outcomes

  1. Maximum observed concentration (Cmax) of Captopril

    Time frame: Up to 3 weeks

  2. Area under the concentration-time curve from administration extrapolated to the last time of quantifiable concentration (AUC[0-t]) of Captopril

    Time frame: Up to 3 weeks

  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of Captopril

    Time frame: Up to 3 weeks

Secondary outcomes

  1. Time to reach Cmax (Tmax) of Captopril

    Time frame: Up to 3 weeks

  2. Terminal elimination halftime (t1/2) of Captopril

    Time frame: Up to 3 weeks

  3. Terminal elimination rate constant (lambda-z) of Captopril

    Time frame: Up to 3 weeks

  4. Percentage of AUC(0-inf) obtained by extrapolation (%AUCex) of Captopril

    Time frame: Up to 3 weeks

  5. Number of participants reporting adverse events (AEs)

    Time frame: Up to 3 weeks

  6. Number of participants with abnormal hematology and biochemistry parameters

    Time frame: Up to 3 weeks

  7. Number of participants with abnormal electrocardiograms (ECGs) and vital signs findings

    Time frame: Up to 3 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04878315
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 7, 2021
Start date
Feb 13, 2022 (estimated)
Primary completion
Mar 25, 2022 (estimated)
Completion
Mar 25, 2022 (estimated)
Last update
Jan 27, 2023

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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