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

This study has been completed.

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00803946

Purpose

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.

Condition	Intervention
Bioequivalency	Drug: Ibuprofen Tablets, 800 mg

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Normal, Healthy Men and Women Following Standard Meal

Further study details as provided by Perrigo Company:

Primary Outcome Measures:

Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	November 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test Product: Active Comparator	Drug: Ibuprofen Tablets, 800 mg
Reference Product: Active Comparator	Drug: Ibuprofen Tablets, 800 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Perrigo Company ( Diane Morgan )
Study ID Numbers:	30275
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00803946
Health Authority:	United States: Institutional Review Board

Keywords provided by Perrigo Company:

bioequivalency
ibuprofen

Study placed in the following topic categories:

Ibuprofen
Malnutrition
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009