Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
healthy men or women, non-smoker, 18 years of age or older
willing to participate and sign a copy of the informed consent form
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