MK0524A Bioequivalence Study (0524A-059)
An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets
3 other identifiers
interventional
188
0 countries
N/A
Brief Summary
This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2006
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedResults Posted
Study results publicly available
November 25, 2009
CompletedJune 19, 2015
May 1, 2015
3 months
July 21, 2009
October 20, 2009
May 25, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Maximum Plasma Concentration (Cmax) of Nicotinuric Acid
Measure of rate of absorption of ER niacin
Predose and up to 24 hours postdose
Total Amount of Urinary Excretion of Niacin and Its Metabolites
Measure of extent of absorption of ER niacin
Predose and up to 96 hours postdose
Area Under Curve (AUC 0-infinity) of Laropiprant
Measure of extent of absorption of laropiprant
Predose and up to 48 hours postdose
Maximum Concentration (Cmax) of Laropiprant
Measure of rate of absorption of laropiprant
Predose and up to 48 hours postdose
Study Arms (2)
A
ACTIVE COMPARATORMK0524A Source 1 (Phase III manufacturing site)
B
ACTIVE COMPARATORMK0524A Source 2 (commercial manufacturing site)
Interventions
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.
Eligibility Criteria
You may qualify if:
- Subject is in good health
- Subject is willing to follow all study guidelines
You may not qualify if:
- Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 23, 2009
Study Start
October 1, 2006
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
June 19, 2015
Results First Posted
November 25, 2009
Record last verified: 2015-05