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

This study has been completed.

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00804401

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
Bioequivalency	Drug: Naproxen Tablets, 500 mg

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

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
Test Product: Active Comparator	Drug: Naproxen Tablets, 500 mg
Reference Product: Active Comparator	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

Responsible Party:	Perrigo Company ( Diane Morgan )
Study ID Numbers:	40061
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00804401
Health Authority:	Canada: Health Canada

Keywords provided by Perrigo Company:

bioequivalency
Naproxen

Study placed in the following topic categories:

Naproxen
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009