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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bioequivalency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Product

Group Type ACTIVE_COMPARATOR

Naproxen Tablets, 500 mg

Intervention Type DRUG

Reference Product

Group Type ACTIVE_COMPARATOR

Naproxen Tablets, 500 mg

Intervention Type DRUG

Interventions

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Naproxen Tablets, 500 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes