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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00959439
First received: August 13, 2009
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).

Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
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 ]

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.)

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959439

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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00959439     History of Changes
Other Study ID Numbers: 11704
Study First Received: August 13, 2009
Last Updated: March 27, 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

ClinicalTrials.gov processed this record on July 25, 2017