To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Phase 1

Completed

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

• Registration Number: NCT00914160
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets under non-fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-08
• Primary Completion: 1993-09
• Study Completion: 1993-09
• 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: 18

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	Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)	Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)
2	Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)	Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)
3	Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)	Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	31 days