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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00804440
First received: December 5, 2008
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Bioequivalency
Drug: Ibuprofen Tablets, 800 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test Product Drug: Ibuprofen Tablets, 800 mg
Active Comparator: Reference Product 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 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT00804440     History of Changes
Other Study ID Numbers: 30470
Study First Received: December 5, 2008
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Perrigo Company:
bioequivalency
ibuprofen

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

ClinicalTrials.gov processed this record on April 17, 2014