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

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

Completed

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Drug

Primary outcomes

Bioequivalence based on AUC and Cmax

Time frame: 55 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.

Important dates

Study start: 2002
Primary completion: 2002
Study completion: 2002
First posted: Aug 14, 2009
Registry last updated: Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed