The objective of this study is to compare pharmacokinetics after single oral administration of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and valsartan in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Yuhan Corporation
Seoul, South Korea
Cmax,ss of valsartan
Time frame: 18 points up to Day 4
AUCt,ss of valsartan
Time frame: 18 points up to Day 4
Cmax,ss of rosuvastatin
Time frame: 18 points up to Day 4
AUCt,ss of rosuvastatin
Time frame: 18 points up to Day 4
t1/2 of rosuvastatin
Time frame: 18 points up to Day 4
Tmax,ss of valsartan
Time frame: 18 points up to Day 4
t1/2 of valsartan
Time frame: 18 points up to Day 4
Cmin,ss of valsartan
Time frame: 18 points up to Day 4
Tmax,ss of rosuvastatin
Time frame: 18 points up to Day 4
Cmin,ss of rosuvastatin
Time frame: 18 points up to Day 4
t1/2 of rosuvastatin
Time frame: 18 points up to Day 4
Cmax,ss of N-desmetyl rosuvastatin
Time frame: 18 points up to Day 4
AUCt,ss of N-desmetyl rosuvastatin
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Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
Time frame: 18 points up to Day 4