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

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: August 13, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)
Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 55 days ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: March 2002
Study Completion Date: May 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)
Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)
Active Comparator: 2
Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)
Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)


Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts 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.
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Please refer to this study by its identifier: NCT00959439

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: Ronald Goldwater, M.D. PharmaKinetics Laboratories Inc.
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00959439     History of Changes
Other Study ID Numbers: 11704 
Study First Received: August 13, 2009
Last Updated: August 13, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 22, 2016