drugset / Trial / NCT01494727
Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg
RandomizedCrossoverOpen-labelTreatment
Summary
The objectives of this study are: * To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers * To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
Timeline
- Start
- 2012-02
- Primary completion
- 2012-04
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amlodipine | Other / unclassified | 10 mg | Oral |
| Comparator | Valsartan | Small molecule | 160 mg | Oral |
Indications
No indication recorded.