Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00966030
First received: August 24, 2009
Last updated: July 3, 2014
Last verified: July 2014
  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

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

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966030

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00966030     History of Changes
Other Study ID Numbers: 0974-042, MK0974-042, 2009_649
Study First Received: August 24, 2009
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 22, 2014