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

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

Completed

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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 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

Treatment and study plan

MK0974 tablet

Drug

MK0974 280 mg tablet in one of two treatment periods

Comparator: MK0974 liquid filled capsule

Drug

MK0974 300 mg liquid filled capsule in one of two treatment periods

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

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.

Published trials that share one or more normalized conditions with this study.

Completed