Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00945035
First received: July 22, 2009
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Pain
Drug: etoricoxib
Drug: Comparator: etoricoxib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ] [ Designated as safety issue: No ]
    The area under the plasma concentration vs time curve.

  • Peak Plasma Concentration (Cmax) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2002
Study Completion Date: April 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945035

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00945035     History of Changes
Other Study ID Numbers: 2009_623, MK0663-070
Study First Received: July 22, 2009
Results First Received: October 13, 2009
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 15, 2014