Status:
COMPLETED
Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 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 Ibuprofen 800 mg Tablets, administered as a 1 x 800 mg tablet, under fed conditions.
Eligibility Criteria
Inclusion
- healthy men or women, 18 years of age or older
- body mass index between 19 and 30
- willing to participate and sign a copy of the informed consent form
Exclusion
- history of allergy or hypersensitivity to ibuprofen
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- use of tobacco products during the past 3 months
- 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 :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00803946
Start Date
November 1 2003
Last Update
March 16 2012
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