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

Organon and Co36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

etoricoxibDRUG

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

Comparator: etoricoxibDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

The area under the plasma concentration vs time curve.

Time frame: Through 120 Hours Postdose

Peak Plasma Concentration (Cmax) for Etoricoxib

Time frame: Through 120 Hours Postdose

Data from ClinicalTrials.gov

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