Overview

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