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: NA
Last verified: August 2009
History: No changes posted
  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
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.)

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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 Inc.
Investigators
Principal Investigator: Ronald Goldwater, M.D. PharmaKinetics Laboratories, Inc.
  More Information

No publications provided

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: August 13, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014