Status:
COMPLETED
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
Lead Sponsor:
Perrigo Company
Conditions:
Bioequivalency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00803764
Start Date
June 1 2004
Last Update
March 16 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.