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The investigators investigate the potential pharmacokinetic drug-drug interaction between Cilnidipine 10 mg and Valsartan 160 mg in healthy male volunteers who receive Cilnidipine 10 mg alone, Valsartan 160 mg , and both together in a 3 period repeatedly.
To evaluate the safety, drug-tolerance, pharmacokinetics of Cilnidipine 10 mg or Valsartan 160 mg monotherapy or Cilnidipine 10 mg and Valsartan 160 mg combination in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C - V - C+V | Experimental | C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time |
|
| V - C - C+V | Experimental | C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time |
|
| V - C+V - C | Experimental | C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time |
|
| C+V - V - C | Experimental | C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time |
|
| C+V - C - V | Experimental | C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C - V - C+V | Drug | Drug will be administered to according to C - V - C+V sequence for 3 period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Cilnidipine 10 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose | |
| Cmax of Valsartan 160 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose | |
| AUClast of Cilnidipine 10 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose | |
| AUClast of Valsartan 160 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Cilnidipine 10 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose | |
| Tmax of Valsartan 160 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoung Sang You, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Jongno-gu | Seoul | 110-744 | South Korea |
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| C - C+V - V | Experimental | C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time |
|
| C - C+V - V | Drug | Drug will be administered to according to C - C+V - V sequence for 3 period. |
|
| V - C - C+V | Drug | Drug will be administered to according to V - C - C+V sequence for 3 period. |
|
| V - C+V - C | Drug | Drug will be administered to according to V - C+V - C sequence for 3 period. |
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| C+V - C - V | Drug | Drug will be administered to according to C+V - C - V sequence for 3 period. |
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| C+V - V - C | Drug | Drug will be administered to according to C+V - V - C sequence for 3 period. |
|
| AUCinf of Cilnidipine 10 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose |
| CL/F of Cilnidipine 10 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose |
| AUCinf of Valsartan 160 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose |
| CL/F of Valsartan 160 mg | 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose |