MK0524A Bioequivalence Study (0524A-059)

Dyslipidemia Clinical Trial

Official title:

An Open Label, Randomized, 2-Period, Crossover Study to Establish the Definitive Bioequivalence of Niacin and MK0524 of 2 Sources of MK0524A Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944645
• Other study ID #: 0524A-059
• Secondary ID: MK0524A-0592009_
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2009
• Last updated: May 25, 2015
• Start date: October 2006
• Est. completion date: January 2007

Study information

• Verified date: May 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 definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject is in good health

• Subject is willing to follow all study guidelines

Exclusion Criteria:

• Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• niacin (+) laropiprant (Source 1)
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.
• Comparator: niacin (+) laropiprant (Source 2)
Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 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	Maximum Plasma Concentration (Cmax) of Nicotinuric Acid	Measure of rate of absorption of ER niacin	Predose and up to 24 hours postdose	No
Primary	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	No
Primary	Area Under Curve (AUC 0-infinity) of Laropiprant	Measure of extent of absorption of laropiprant	Predose and up to 48 hours postdose	No
Primary	Maximum Concentration (Cmax) of Laropiprant	Measure of rate of absorption of laropiprant	Predose and up to 48 hours postdose	No