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CompletedNCT00835354Updated Aug 20, 2024Results posted

Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting

A Phase 1 interventional study of Cefprozil for oral suspension 250 mg/5 mL and CEFZIL® for Oral Suspension 250 mg/5mL in Healthy, sponsored by Teva Pharmaceuticals USA. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Teva Pharmaceuticals USA · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under non-fasting conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • Healthy Subjects
03

In context

Lead sponsor

Teva Pharmaceuticals USA is the lead sponsor of 171 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.
  • Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
  • Each female subject will be given a serum pregnancy test as part of the pre-study screening process.
  • Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.

  • Clinical laboratory measurements will include the following:

    1. Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).
    2. Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.
    3. Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
    4. HIV Screen: pre-study only.
    5. Hepatitis-B, C Screen: pre-study only.
    6. Drugs of Abuse Screen: pre-study and at each check-in

Exclusion criteria

Exclusion Criteria:

  • Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.
  • All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
05

Study design

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

Study arms

  • Experimental
    1

    Drug: Cefprozil for oral suspension 250 mg/5 mL

  • Active comparator
    2

    Drug: CEFZIL® for Oral Suspension 250 mg/5mL

Interventions

  • DrugCefprozil for oral suspension 250 mg/5 mL

    1 x 250 mg/5 mL, single-dose fasting

  • DrugCEFZIL® for Oral Suspension 250 mg/5mL

    1 x 250 mg/5 mL, single-dose fasting

06

What researchers measure

Primary outcomes

  1. Cmax (Maximum Observed Concentration)

    Bioequivalence based on Cmax.

    Time frame: Blood samples collected over a 12 hour period.

  2. AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

    Bioequivalence based on AUC0-t.

    Time frame: Blood samples collected over a 12 hour period.

  3. AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

    Bioequivalence based on AUC0-inf.

    Time frame: Blood samples collected over a 12 hour period.

07

Results

Posted Jul 21, 2009

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneCefprozil (Test) FirstCefzil® (Reference) First
Started1313
Completed1312
Not completed01
Withdrew: Adverse event01
Washout of 7 Days
Participant flow — Washout of 7 Days
MilestoneCefprozil (Test) FirstCefzil® (Reference) First
Started1312
Completed1312
Not completed00
Second Intervention
Participant flow — Second Intervention
MilestoneCefprozil (Test) FirstCefzil® (Reference) First
Started1312
Completed1312
Not completed00

Outcome measures

PrimaryCmax (Maximum Observed Concentration)

Bioequivalence based on Cmax.

Time frame:
Blood samples collected over a 12 hour period.
Reported as:
Mean · ng/mL
Cmax (Maximum Observed Concentration)
ng/mLCefprozil (Test)Cefzil® (Reference)
Cmax (Maximum Observed Concentration)4.367 ± 0.7114.915 ± 0.859
Statistical analysis
  • Cefprozil (Test) vs Cefzil® (Reference) · Ratio of the t/r geometric mean x 100: 89.2 · 90% CI 86.2 to 92.2Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
PrimaryAUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t.

Time frame:
Blood samples collected over a 12 hour period.
Reported as:
Mean · ng*h/mL
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
ng*h/mLCefprozil (Test)Cefzil® (Reference)
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)14.211 ± 2.1515.776 ± 2.702
Statistical analysis
  • Cefprozil (Test) vs Cefzil® (Reference) · Ratio of the t/r geometric mean x 100: 90.5 · 90% CI 88.9 to 92.1Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
PrimaryAUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on AUC0-inf.

Time frame:
Blood samples collected over a 12 hour period.
Reported as:
Mean · ng*h/mL
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
ng*h/mLCefprozil (Test)Cefzil® (Reference)
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)14.495 ± 2.20416.048 ± 2.72
Statistical analysis
  • Cefprozil (Test) vs Cefzil® (Reference) · Ratio of the t/r geometric mean x 100: 90.7 · 90% CI 89.1 to 92.3Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cefprozil (Test) FirstCefzil® (Reference) FirstTotal
<=18 years000
Between 18 and 65 years131326
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Cefprozil (Test) FirstCefzil® (Reference) FirstTotal
Female8513
Male5813
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Cefprozil (Test) FirstCefzil® (Reference) FirstTotal
Black202
White111324
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cefprozil (Test) FirstCefzil® (Reference) FirstTotal
Hispanic or Latino011
Not Hispanic or Latino131225
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Cefprozil (Test) FirstCefzil® (Reference) FirstTotal
United States131326
08

Study locations

2 sites
  • Gateway Medical Research, Inc.
    Saint Charles, Missouri 63301, United States
  • Bioassay Laboratory, Inc.
    Houston, Texas 77099, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00835354
Lead sponsor
Teva Pharmaceuticals USA
First posted
Feb 3, 2009
Start date
May 2004
Primary completion
May 2004
Completion
May 2004
Results posted
Jul 21, 2009
Last update
Aug 20, 2024

Study contacts

Steven Herrmann, M.D.
principal investigator · Cetero Research, San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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