Overview

Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 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 Ibuprofen 800 mg Tablets, administered as a single, one-tablet dose in fasted subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Perrigo Company
Treatments:
Ibuprofen
Criteria
Inclusion Criteria:

- 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 Criteria:

- history of allergy or hypersensitivity to ibuprofen

- recent history of drug or alcohol addiction or abuse

- pregnant or lactating women

- use of tobacco products within 3 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