Cefadroxil 500 mg Capsules Under Fasting Conditions

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 fasting conditions.

Timeline

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

Outcome

Met primary endpoint

registry analysis (unspecified test); Cefadroxil (Test) vs Duricef® (Reference); Ratio of the T/R geometric mean x 100 99 (90% CI 94 to 104) NCT00834275 ↗

registry analysis (unspecified test); Cefadroxil (Test) vs Duricef® (Reference); Ratio of the T/R geometric mean x 100 101 (90% CI 98.3 to 105) NCT00834275 ↗

registry analysis (unspecified test); Cefadroxil (Test) vs Duricef® (Reference); Ratio of the T/R geometric mean x 100 101 (90% CI 98.3 to 104) NCT00834275 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefadroxil	Small molecule	500 mg	—

Indications

No indication recorded.