CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 220 enrolled
Drug / intervention
MK0524B (ER niacin (+) laropiprant (+) simvastatin) +2 moredrug
Likely dose
MK0524B (ER niacin (+) laropiprant (+) simvastatin) 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00943124
NCT00943124Phase 1Completed
CompareCT.gov

An Open-Label, Definitive Bioequivalence Study to Compare the Pharmacokinetics of the Simvastatin, Nicotinic Acid, and MK0524 (Laropiprant) Components of a Formulation of MK0524B With That of Zocor™ and MK0524A Tablets

Merck Sharp & Dohme LLC·interventional·Posted Jul 22, 2009·Updated Jun 19, 2015

In Brief

A Phase 1 clinical trial evaluating MK0524B (ER niacin (+) laropiprant (+) simvastatin), MK0524A (ER niacin + laropiprant), and 1 other intervention for Dyslipidemia. Completed, enrolled 220 participants.

Detailed Summary

This study will evaluate: 1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B. 2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2009
Enrollment StartJul 1, 2007
Primary CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago

Interventions

MK0524B (ER niacin (+) laropiprant (+) simvastatin)drug

Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.

MK0524A (ER niacin + laropiprant)drug

Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.

Simvastatindrug

Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.