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

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

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: etoricoxib; Drug: Comparator: etoricoxib

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Etoricoxib, 20% tablet	Drug: etoricoxib; Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.
Active Comparator: B; Etoricoxib, 30% tablet	Drug: Comparator: etoricoxib; Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): December 1, 2002
• Study Completion (Actual): December 1, 2002

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: 0663-070; MK0663-070; 2009_623