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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis; Rheumatoid Arthritis

Treatments: Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.); Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959439

11704

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

1

Experimental group

Description:

Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)

Treatment:

Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)

2

Active Comparator group

Description:

Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Treatment:

Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)