Status:

COMPLETED

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

Lead Sponsor:

Perrigo Company

Conditions:

Bioequivalency

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00804440

Start Date

January 1 2004

Last Update

March 16 2012

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