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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Perrigo Company
• Treatments: Naproxen

Criteria

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