NCT00803946

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

December 5, 2008

Last Update Submit

March 15, 2012

Conditions

Bioequivalency

Keywords

bioequivalencyibuprofen

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity

Study Arms (2)

Test Product

ACTIVE COMPARATOR
Drug: Ibuprofen Tablets, 800 mg

Reference Product

ACTIVE COMPARATOR
Drug: Ibuprofen Tablets, 800 mg

Interventions

Ibuprofen Tablets, 800 mgDRUG
Reference ProductTest Product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

November 1, 2003

Primary Completion

November 1, 2003

Last Updated

March 16, 2012

Record last verified: 2012-03