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

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.

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