drugset / Trial / NCT00834574

Cefdinir for Oral Suspension 250 mg/5mL, Fasting

NCT00834574 ↗

Phase 1 Completed 32 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects under fasting conditions.

Timeline

Start
2005-02
Primary completion
2005-03
Completion
2005-03

Outcome

Met primary endpoint

registry analysis (unspecified test); Cefdinir (Test) vs Omnicef® (Reference); Ratio of the T/R geometric mean x 100 103 (90% CI 97.2 to 110) NCT00834574 ↗

registry analysis (unspecified test); Cefdinir (Test) vs Omnicef® (Reference); Ratio of the T/R geometric mean x 100 107 (90% CI 101 to 114) NCT00834574 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject cefdinir Other / unclassified 250 mg Oral

Indications

No indication recorded.