To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets

Phase 1

Completed

• Conditions: Inflammation
• Interventions: Drug: Voltaren 50 mg Tablets (Geigy Pharmaceuticals); Drug: Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)

• Registration Number: NCT00913224
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-04
• Primary Completion: 1993-04
• Study Completion: 1993-04
• Status Verified: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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
2	Voltaren 50 mg Tablets (Geigy Pharmaceuticals)	Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
1	Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)	Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	17 days