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

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.

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Key information

Conditions

Bioequivalency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen Tablets, 800 mg

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Perrigo Company

Industry

Registry information

Official study title

A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Fasted Normal, Healthy Subjects

Important dates

Study start: 2004
Primary completion: 2004
First posted: Dec 8, 2008
Registry last updated: Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed