drugset / Trial / NCT00835081

Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.

NCT00835081 ↗

Phase 1 Completed 26 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.

Timeline

Start
2004-09
Primary completion
2004-10
Completion
2004-10

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 103 (90% CI 95.9 to 110) NCT00835081 ↗

registry Ratio of the T/R geometric mean x 100 100 (90% CI 97.5 to 103) NCT00835081 ↗

registry Ratio of the T/R geometric mean x 100 99.8 (90% CI 97.4 to 102) NCT00835081 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefadroxil Small molecule 500 mg —

Indications

No indication recorded.