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Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00966030
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.


Condition Intervention Phase
Migraine
 Drug: MK0974 tablet
Drug: Comparator: MK0974 liquid filled capsule
 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 Demonstrate the Definitive Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate Vs. a Single Dose of the Reference MK0974 Liquid Filled Capsule 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 tablet formulation and MK0974 liquid filled capsule formulation [ Time Frame: Through 48 Hours Post Dose ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation [ Time Frame: Through 48 Hours Post Dose ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0974 Tablet
 Drug: MK0974 tablet
MK0974 280 mg tablet in one of two treatment periods
Active Comparator: 2
MK0974 Liquid filled capsule
 Drug: Comparator: MK0974 liquid filled capsule
MK0974 300 mg liquid filled capsule 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 nonsmoker
  • Subject is willing to comply with the study restrictions

Exclusion Criteria:

  • Subject has history of stroke, chronic seizures, or any major neurological disorder
  • Subject has a history of cancer
  • Subject is a nursing mother
  • Subject has uncontrolled high blood pressure
  • Subject has or has a history of any disease or condition that might made participation in the study unsafe or confound the study results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966030

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: NCT00966030     History of Changes
Other Study ID Numbers: 2009_649, MK0974-042
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 22, 2013