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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: etoricoxib

• Registration Number: NCT00945035
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Results First Submitted: 2009-10-13
• Results First Submitted QC: 2009-10-13
• Results First Posted: 2009-11-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	etoricoxib	Etoricoxib, 20% tablet

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) for Etoricoxib	Through 120 Hours Postdose
Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib	Through 120 Hours Postdose	The area under the plasma concentration vs time curve.