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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804440
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bioequivalency Drug: Ibuprofen Tablets, 800 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Fasted Normal, Healthy Subjects
Study Start Date : January 2004
Actual Primary Completion Date : January 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Test Product Drug: Ibuprofen Tablets, 800 mg
Active Comparator: Reference Product Drug: Ibuprofen Tablets, 800 mg

Primary Outcome Measures :
  1. Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Perrigo Company Identifier: NCT00804440     History of Changes
Other Study ID Numbers: 30470
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Perrigo Company:

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action