Phase 1
Completed N=188
MK0524A Bioequivalence Study (0524A-059)
Source: ClinicalTrials.gov NCT00944645 ↗Enrolled (actual)
188
Serious AEs
0.5%
Results posted
Nov 2009
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Nicotinuric Acid — 1190; 1260 ng/mL
Summary
This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Nicotinuric Acid |
1190; 1260 | — |
| PRIMARY Total Amount of Urinary Excretion of Niacin and Its Metabolites |
5280; 5470 | — |
| PRIMARY Area Under Curve (AUC 0-infinity) of Laropiprant |
6.36; 6.37 | — |
| PRIMARY Maximum Concentration (Cmax) of Laropiprant |
0.988; 0.975 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00944645). 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.