We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00945035
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : November 17, 2009
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: etoricoxib Drug: Comparator: etoricoxib Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2002
Primary Completion Date : December 2002
Study Completion Date : December 2002
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ]
    The area under the plasma concentration vs time curve.

  2. Peak Plasma Concentration (Cmax) for Etoricoxib [ Time Frame: Through 120 Hours Postdose ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945035


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00945035     History of Changes
Other Study ID Numbers: 0663-070
MK0663-070
2009_623
First Posted: July 23, 2009    Key Record Dates
Results First Posted: November 17, 2009
Last Update Posted: July 3, 2015
Last Verified: June 2015

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