NCT00882154

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fed State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cefdinir 300 mg Capsule (Sandoz, Austria)
DRUG	Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2009-04-16
• Last updated: 2017-03-29