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NCT00945035 Clinical Trial

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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00945035
Other study ID # 0663-070
Secondary ID MK0663-0702009_6
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2002
Est. completion date December 2002

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date December 2002
Est. primary completion date December 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• etoricoxib
Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.
• Comparator: etoricoxib
Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib The area under the plasma concentration vs time curve. Through 120 Hours Postdose
Primary Peak Plasma Concentration (Cmax) for Etoricoxib Through 120 Hours Postdose
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