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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

August 24, 2009
August 24, 2009
March 2008
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974
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

This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Migraine
  • Drug: MK0974 tablet
    MK0974 280 mg tablet in one of two treatment periods
  • Drug: Comparator: MK0974 liquid filled capsule
    MK0974 300 mg liquid filled capsule in one of two treatment periods
  • Experimental: 1
    MK0974 Tablet
    Intervention: Drug: MK0974 tablet
  • Active Comparator: 2
    MK0974 Liquid filled capsule
    Intervention: Drug: Comparator: MK0974 liquid filled capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00966030
2009_649, MK0974-042
No
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP