Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)

Phase 1

Completed

• Conditions: Rheumatoid Arthritis; Osteoarthritis
• Interventions: Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.); Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

• Registration Number: NCT00959439
• Lead Sponsor: Sandoz

Brief Summary

The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2002-05
• Study Completion: 2002-05
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)	Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)
2	Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)	Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	55 days