CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Cefprozil for oral suspension 250 mg/5 mL +1 moredrug
Likely dose
Cefprozil 250 mg/5 mL oral suspension, single doseAI-extracted
Key inclusion· 4
  • ✓Non-smokers at least 18 years of age
  • ✓BMI of 30 or less
  • ✓General physical examination within 28 days of study initiation
  • ✓Normal or non-significant clinical laboratory test values
Key exclusion· 8
  • ✕Significant recent history of chronic alcohol consumption (past 2 years)
  • ✕Drug addiction or gastrointestinal, renal, hepatic, or cardiovascular disease
  • ✕Tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis, or glaucoma
  • ✕History of allergic responses to cephalosporin class of drugs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00835354
NCT00835354Phase 1Completed
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A Relative Bioavailability Study of Cefprozil for Oral Suspension 250 mg/5 mL Under Non-Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Feb 3, 2009·Updated Aug 20, 2024

In Brief

A Phase 1 clinical trial evaluating Cefprozil for oral suspension 250 mg/5 mL and CEFZIL® for Oral Suspension 250 mg/5mL for Healthy. Completed, enrolled 26 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartMay 1, 2004
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

Cefprozil for oral suspension 250 mg/5 mLdrug

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

CEFZIL® for Oral Suspension 250 mg/5mLdrug

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