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

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ClinicalTrials.gov Identifier: NCT00959439
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis 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  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.
Study Start Date : March 2002
Actual Primary Completion Date : May 2002
Actual Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 55 days ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959439


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00959439     History of Changes
Other Study ID Numbers: 11704
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

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