Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)

This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

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

Subject is in good health
Subject agrees to follow the study guidelines

Exclusion criteria

Subject is a smoker
Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs
Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study

Treatment and study plan

Etoricoxib

Drug

Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.

Comparator: etoricoxib

Drug

Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

Primary outcomes

Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib

Time frame: Through 120 Hours Postdose

The area under the plasma concentration vs time curve.
Peak Plasma Concentration (Cmax) for Etoricoxib

Time frame: Through 120 Hours Postdose

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations

Important dates

Study start: 2002
Primary completion: 2002
Study completion: 2002
First posted: Jul 23, 2009
Registry last updated: Feb 9, 2022

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