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

Perrigo

Status and phase: Completed; Phase 1

Conditions: Bioequivalency

Treatments: Drug: Ibuprofen Tablets, 800 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803946

30275

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Test Product

Active Comparator group

Treatment:

Drug: Ibuprofen Tablets, 800 mg

Reference Product

Active Comparator group

Treatment:

Drug: Ibuprofen Tablets, 800 mg