NCT00883883

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions

A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fed State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
DRUG	Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2009-04-20
• Last updated: 2017-03-29