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Bioequivalence of Two Tablet Forms of MK0974 (0974-045)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965887
First Posted: August 26, 2009
Last Update Posted: July 7, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will evaluate the bioequivalence of two solid dose formulations of MK0974.

Condition Intervention Phase
Migraine Drug: MK0974 Ethanolate formulation Drug: Comparator: MK0974 Hydrate formulation Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate vs. a Single Dose of a Tablet Form of MK0974 Hydrate in Healthy Subjects

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

Primary Outcome Measures:
  • Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations [ Time Frame: Through 48 hours postdose ]
  • Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations [ Time Frame: Through 48 Hours Post Dose ]

Enrollment: 36
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
MK0974 Ethanolate
Drug: MK0974 Ethanolate formulation
Single dose MK0974 280 mg tablet in one of two treatment periods
Active Comparator: 2
MK0974 Hydrate
Drug: Comparator: MK0974 Hydrate formulation
Single dose MK0974 280 mg tablet in one of two treatment periods

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good health
  • Subject is a non-smoker
  • Subject is willing to comply with the study restrictions

Exclusion Criteria:

  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of cancer
  • Subject is a nursing mother
  • Subject has or has a history of any disease or condition that might make participation in the study unsafe or that might confound the results of 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): NCT00965887


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: NCT00965887     History of Changes
Other Study ID Numbers: 0974-045
MK0974-045
2009_650
First Submitted: August 24, 2009
First Posted: August 26, 2009
Last Update Posted: July 7, 2015
Last Verified: July 2015