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OpenTrials
Completed

NCT Number: NCT00965887

Bioequivalence of Two Tablet Forms of MK0974 (0974-045)

This study will evaluate the bioequivalence of two solid dose formulations of MK0974.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0974 Ethanolate formulation

Drug

Single dose MK0974 280 mg tablet in one of two treatment periods

Comparator: MK0974 Hydrate formulation

Drug

Single dose MK0974 280 mg tablet in one of two treatment periods

Primary outcomes

  1. Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations

    Time frame: Through 48 hours postdose

  2. Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations

    Time frame: Through 48 Hours Post Dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2009
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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