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Single Dose Open-label Comparative Pharmacokinetic Study to Assess the Pharmacokinetic Characteristics of Irbesartan and Atorvastatin Between Irbesartan/Atorvastatin Combination Tablet and Coadministration of Irbesartan and Atorvastatin Tablets in Healthy Male Subjects
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912
Details
| Lead sponsor | Hanmi Pharmaceutical Company Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 52 |
| Start date | 2011-09 |
| Completion | 2011-12 |
Conditions
- Healthy
Interventions
- HCP0912 / Irbesartan and Atorvastatin
Primary outcomes
- AUC of Irbesartan — 0-48 hrs
- AUC of Atorvastatin and 2-hydroxy atorvastatin — 0-48 hrs
- Cmax of Irbesartan — 0-48 hrs
- Cmax of Atorvastatin and 2-hydroxy atorvastatin — 0-48 hrs
Countries
South Korea