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

Phase 1

Completed

• Conditions: Bioequivalency
• Interventions: Drug: Ibuprofen Tablets, 800 mg

• Registration Number: NCT00804440
• Lead Sponsor: Perrigo Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-01
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Product	Ibuprofen Tablets, 800 mg	-
Reference Product	Ibuprofen Tablets, 800 mg	-

Primary Outcome Measures

Name	Time	Method
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity