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Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin
This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2004-03 |
| Completion | 2004-09 |
Conditions
- Hypercholesterolemia
Interventions
- SCH 58235
- pitavastatin
Primary outcomes
- Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h). — Day 7 of each period