drugset / Trial / NCT00835354

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

NCT00835354 ↗

Phase 1 Completed 26 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2004-05
Primary completion
2004-05
Completion
2004-05

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 89.2 (90% CI 86.2 to 92.2) NCT00835354 ↗

registry Ratio of the T/R geometric mean x 100 90.5 (90% CI 88.9 to 92.1) NCT00835354 ↗

registry Ratio of the T/R geometric mean x 100 90.7 (90% CI 89.1 to 92.3) NCT00835354 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CEFPROZIL ANHYDROUS, (E)- Small molecule 250 mg Oral

Indications

No indication recorded.