Phase 1
Completed N=220
MK0524B Bioequivalence Study (0524B-070)
Source: ClinicalTrials.gov NCT00943124 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid — 9.19; 8.03 ng/mL * Hour
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid |
9.19; 8.03 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of Simvastatin Acid |
1.016; 0.918 | — |
| PRIMARY Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin |
15.03; 15.56 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of Simvastatin |
5.81; 6.33 | — |
| PRIMARY Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant |
5486; 5405 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of Laropiprant |
1030; 953 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of Nicotinuric Acid |
620; 807 | — |
| PRIMARY Total Urinary Excretion of Niacin and Its Metabolites |
5339; 5825 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is in good health
- Subject is a nonsmoker
- Subject is willing to follow the study guidelines
Exclusion Criteria
- Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject
Data sourced from ClinicalTrials.gov (NCT00943124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.