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

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

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

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: MK0974 Ethanolate formulation; Drug: Comparator: MK0974 Hydrate formulation

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; MK0974 Ethanolate	Drug: MK0974 Ethanolate formulation; Single dose MK0974 280 mg tablet in one of two treatment periods
Active Comparator: 2; MK0974 Hydrate	Drug: Comparator: MK0974 Hydrate formulation; Single dose MK0974 280 mg tablet in one of two treatment periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations	Through 48 hours postdose
Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations	Through 48 Hours Post Dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 26, 2009

Study Record Updates

• Last Update Posted (Estimate): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 3, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 0974-045; MK0974-045; 2009_650