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