NCT00835549

Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting

A Relative Bioavailability Study of Cefdinir for Oral Suspension 250 mg/5mL Under Non-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

The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects under non-fasting conditions.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cefdinir for oral suspension 250 mg/5mL	1 x 250 mg/5mL, single-dose non-fasting
DRUG	OMNICEF® for oral suspension 250 mg/5mL	1 x 250 mg/5mL, single-dose non-fasting

Timeline

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

Locations

2 sites across 1 country: United States