Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00943124 | MK0524B Bioequivalence Study (0524B-070) | PHASE1 | COMPLETED | 220 | — | — | Jul 1, 2007 | Aug 1, 2007 | Jun 19, 2015 | - | — |
Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Plasma Area Under the Curve of simvastatin
Plasma Area Under the Curve of Laropiprant
Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
| Arm | Type | Description |
|---|---|---|
| MK0524B then Simvastatin + MK0524A | EXPERIMENTAL | Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. |
| Simvastatin + MK0524A then MK0524B | EXPERIMENTAL | Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). |
| Name | Type | Description |
|---|---|---|
| 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. |
| Simvastatin | DRUG | Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods. |
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