drugset / Trial / NCT00835549

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

NCT00835549 ↗

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 non-fasting conditions.

Timeline

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

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 98.6 (90% CI 94.8 to 102) NCT00835549 ↗

registry Ratio of the T/R geometric mean x 100 102 (90% CI 98.5 to 105) NCT00835549 ↗

registry Ratio of the T/R geometric mean x 100 102 (90% CI 98.7 to 105) NCT00835549 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject cefdinir Other / unclassified 250 mg Oral

Indications

No indication recorded.