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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959439

Enrollment

Registered

2009-08-14

Start date

2002-03-31

Completion date

2002-05-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Rheumatoid Arthritis

Brief summary

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

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	55 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026