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

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ClinicalTrials.gov Identifier: NCT00803764
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Perrigo Company

Brief Summary:
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 or disease Intervention/treatment Phase
Bioequivalency Drug: Naproxen Tablets, 500 mg 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: 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
Study Start Date : June 2004
Primary Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Test Product Drug: Naproxen Tablets, 500 mg
Active Comparator: Reference Product Drug: Naproxen Tablets, 500 mg

Primary Outcome Measures :
  1. Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT00803764     History of Changes
Other Study ID Numbers: 40062
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

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
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action