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

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

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
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:

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 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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00966030

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. 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 processed this record on April 22, 2014