Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fasting Conditions

A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Fasted Normal, Healthy Subjects

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.

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