The purpose of this study is to evaluate the drug-drug interaction of CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)
A randomized, open-label, multiple-dose, two-arm, one-sequence · crossover study to evaluate the safety and pharmacokinetics after oral concurrent administration telmisartan/s-amlodipine and rosuvastatin in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Telmisartan/S-Amlodipine 40/2.5mg 2T PO, QD for 9days
Rosuvastatin 20mg 1T PO, QD for 5days
Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days
The catholic university of Korea, seoul ST.Mary's hospital
Seoul, Gangnam-gu, South Korea
AUCt,ss of Telmisartan/S-Amlodipine
Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
Cmax,ss of Telmisartan/S-Amlodipine
Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
AUCt,ss of Rosuvastatin
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
Cmax,ss of Rosuvastatin
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
Tmax,ss of Telmisartan/S-Amlodipine
Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
T1/2 of Telmisartan/S-Amlodipine
Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
CL/F of Telmisartan/S-Amlodipine
Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
Vd/F of Telmisartan/S-Amlodipine
Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
R of Telmisartan/S-Amlodipine
Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24h
Tmax,ss of Rosuvastatin
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
T1/2 of Rosuvastatin
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 9days
CL/F of Rosuvastatin
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
Vd/F of Rosuvastatin
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h
R of Rosuvastatin
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24h