Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bioequivalency
Intervention: Naproxen Tablets, 500 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Perrigo Company
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.
Clinical Details
Official title: 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 Fed Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2004
Last updated: March 15, 2012
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