Primary objective : To investigate pharmacokinetics after concomitant administration of valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in healthy male volunteers Secondary objective : To investigate safety profiles after the administration of valsartan or rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Clinical Trial Center, Samsung Medical Center
Seoul, South Korea
PK parameters of valsartan and rosuvastatin
Cmax,ss and AUCτ,ss of valsartan and rosuvastatin
Time frame: 0h (pre-dosing on 6d, 20d, 34d) and 0h (pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 48h, and 72h (on 7d, 21d, 35d). Day 1 0h (only in period 1)
PK parameters of valsartan and rosuvastatin
* Tmax,ss, Cmin,ss, t1/2,β of valsartan and rosuvastatin * Cmax,ss and AUCτ,ss of N-desmethyl rosuvastatin
Time frame: 0h (pre-dosing on 6d, 20d, 34d) and 0h (pre-dosing), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 48h, and 72h (on 7d, 21d, 35d). Day 1 0h (only in period 1)
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Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug