drugset
drugset / Trial / NCT00835484

Cefdinir Capsules 300 mg, Fasting

NCT00835484 ↗

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 fasting conditions.

Timeline

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

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 97.15 (90% CI 91.77 to 102.83) NCT00835484 ↗

registry Ratio of the T/R geometric mean x 100 100.8 (90% CI 95.1 to 106.84) NCT00835484 ↗

registry Ratio of the T/R geometric mean x 100 101.39 (90% CI 95.89 to 107.2) NCT00835484 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject cefdinir Other / unclassified 300 mg Oral

Indications

No indication recorded.