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

Perrigo

Status and phase: Completed; Phase 1

Conditions: Bioequivalency

Treatments: Drug: Naproxen Tablets, 500 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803764

40062

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Test Product

Active Comparator group

Treatment:

Drug: Naproxen Tablets, 500 mg

Reference Product

Active Comparator group

Treatment:

Drug: Naproxen Tablets, 500 mg