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Bioequivalence of Two Tablet Forms of MK0974

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00965887
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Migraine
U.S. FDA Resources

Further study details as provided by Merck:

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 ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations [ Time Frame: Through 48 Hours Post Dose ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2008
Study Completion Date: August 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965887

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00965887     History of Changes
Other Study ID Numbers: 2009_650, MK0974-045
Study First Received: August 24, 2009
Last Updated: August 24, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013