NCT00835484

Cefdinir Capsules 300 mg, Fasting

A Relative Bioavailability Study of 300 mg Cefdinir Capsules Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cefdinir Capsules 300 mg	1 x 300 mg, single-dose fasting
DRUG	OMNICEF® 300 mg	1 x 300 mg, single-dose fasting

Timeline

• Start date: 2005-07-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2009-02-03
• Last updated: 2024-08-20
• Results posted: 2009-07-21

Locations

2 sites across 1 country: United States