Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)
July 3, 2015 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
MK0974 Tablet
|
MK0974 280 mg tablet in one of two treatment periods
|
|
Active Comparator: 2
MK0974 Liquid filled capsule
|
MK0974 300 mg liquid filled capsule 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 tablet formulation and MK0974 liquid filled capsule formulation
Time Frame: Through 48 Hours Post Dose
|
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
|
Through 48 Hours Post Dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
- 0974-042
- MK0974-042
- 2009_649
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.