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

Migraine Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965887
• Other study ID #: 0974-045
• Secondary ID: MK0974-0452009_6
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2009
• Last updated: July 3, 2015
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• MK0974 Ethanolate formulation
Single dose MK0974 280 mg tablet in one of two treatment periods
• Comparator: MK0974 Hydrate formulation
Single dose MK0974 280 mg tablet in one of two treatment periods

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations		Through 48 hours postdose	No
Primary	Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations		Through 48 Hours Post Dose	No