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

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

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalency
• Intervention / Treatment: Drug: Naproxen Tablets, 500 mg

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Test Product	Drug: Naproxen Tablets, 500 mg
ACTIVE_COMPARATOR: Reference Product	Drug: Naproxen Tablets, 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity

Collaborators and Investigators

• Sponsor: Perrigo Company

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (ACTUAL): July 1, 2004

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (ESTIMATE): December 8, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: naproxen; bioequivalency
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: 40062