Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions

This study has been completed.
Information provided by (Responsible Party):
Perrigo Company Identifier:
First received: December 5, 2008
Last updated: March 15, 2012
Last verified: March 2012

Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fed conditions.

Condition Intervention Phase
Drug: Naproxen Tablets, 500 mg
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: Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fed Conditions

Resource links provided by NLM:

Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: June 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test Product Drug: Naproxen Tablets, 500 mg
Active Comparator: Reference Product Drug: Naproxen Tablets, 500 mg


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy men or women, non-smoker, 18 years of age or older
  • willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

  • clinically significant illnesses or surgery within 4 weeks prior to study dosing
  • body mass index greater than or equal to 30.0
  • recent history of drug or alcohol addiction or abuse
  • pregnant or lactating women
  • history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
  • history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs
  • history or known presence of gastrointestinal ulceration, bleeding and perforation
  • use of tobacco products within 6 months prior to study dosing
  • evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
  • receipt of any drugs as part of a research study within 30 days prior to study dosing
  Contacts and Locations
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  More Information

No publications provided

Responsible Party: Perrigo Company Identifier: NCT00803764     History of Changes
Other Study ID Numbers: 40062
Study First Received: December 5, 2008
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by Perrigo Company:

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on April 17, 2014