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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Drug will be administered to according to C - V - C+V sequence for 3 period.
Drug will be administered to according to C - C+V - V sequence for 3 period.
Drug will be administered to according to V - C - C+V sequence for 3 period.
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Cmax of Cilnidipine 10 mg
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
Tmax of Cilnidipine 10 mg
Time frame: 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
Time frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
AUCinf of Cilnidipine 10 mg
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
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Drug will be administered to according to V - C+V - C sequence for 3 period.
Drug will be administered to according to C+V - C - V sequence for 3 period.
Drug will be administered to according to C+V - V - C sequence for 3 period.