drugset / Trial / NCT00834535

Cefdinir Capsules 300 mg, Non-fasting

NCT00834535 ↗

Phase 1 Completed 32 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 300 mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a single oral dose (1 x 300mg capsule) in healthy adult subjects administered under non-fasting conditions.

Timeline

Start
2005-07
Primary completion
2005-08
Completion
2005-08

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 100.83 (90% CI 93.98 to 108.17) NCT00834535 ↗

registry Ratio of the T/R geometric mean x 100 96.1 (90% CI 92.14 to 100.22) NCT00834535 ↗

registry Ratio of the T/R geometric mean x 100 96.57 (90% CI 92.8 to 100.49) NCT00834535 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject cefdinir Other / unclassified 300 mg Oral

Indications

No indication recorded.