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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00945035
First received: July 22, 2009
Last updated: May 8, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00945035     History of Changes
Other Study ID Numbers: 0663-070, MK0663-070, 2009_623
Study First Received: July 22, 2009
Results First Received: October 13, 2009
Last Updated: May 8, 2014
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 July 26, 2014