To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cefdinir 300 mg Capsule (Sandoz, Austria); Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

• Registration Number: NCT00882700
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2009-04
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Cefdinir 300 mg Capsule (Sandoz, Austria)	Cefdinir 300 mg Capsule (Sandoz, Austria)
2	Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)	Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	14 days