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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00804401
First received: December 5, 2008
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Bioequivalency
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 Fasting 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

  Eligibility

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

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT00804401     History of Changes
Other Study ID Numbers: 40061
Study First Received: December 5, 2008
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by Perrigo Company:
bioequivalency
Naproxen

Additional relevant MeSH terms:
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 April 17, 2014