NCT00944645|CompletedPhase 1Results
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
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Sponsor study identifier
Secondary identifiers
interventional
188
0 countries
N/A
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2007
Actual (reported)Study Completion
January 2007
Actual (reported)This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
January 2007
Actual (reported)January 2007
Actual (reported)July 21, 2009
Actual (reported)July 23, 2009
Actual (reported)November 25, 2009
Actual (reported)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
MK0524A Source 1 (Phase III manufacturing site)
MK0524A Source 2 (commercial manufacturing site)
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.
Medical Monitor
Merck Sharp & Dohme LLC
188 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2009
First Posted
July 23, 2009
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)
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Primary Completion
January 2007
Actual (reported)Study Completion
January 2007
Actual (reported)Last Updated
June 19, 2015
Results First Posted
November 25, 2009
Record last verified: 2015-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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