This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration. Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration. The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period. The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
48
For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.
Severance Hospital, Yonsei University
Seoul, South Korea
AUC
AUC τ,ss of Rosuvastatin and Telmisartan
Time frame: 72hr
Cmax
Cmax,ss of Rosuvastatin and Telmisartan
Time frame: 72hr
AUC
AUC last,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
AUC
AUC inf,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
Tmax
Tmax,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
t1/2
t1/2 of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
Cmin
Cmin,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Time frame: 72hr
AUC
AUCτ,ss of N-desmetyl Rosuvastatin
Time frame: 72hr
Cmax
Cmax,ss of N-desmetyl Rosuvastatin
Time frame: 72hr
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