The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic properties of Telmisartan/S-amlodipine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
* Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day * Atorvastatin 40mg: 1 tablet, oral, once daily, 2days * over the period I \& II(cross-over)
* Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day * over the period I \& II(cross-over)
Severance Hospital
Seoul, South Korea
In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClast
AUClast = Area under the plasma concentration-time curve from zero time until the last measurable concentration
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
In the steady state Telmisartan 80mg and S-amlodipine 5mg Cmax
Cmax=Maximum Plasma Drug Concentration
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine: Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinf
AUCinf=Area under the plasma concentration-time curve from time zero to infinity
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
In the steady state Telmisartan 80mg & S-amlodipine 5mg Tmax
Tmax=Time to Cmax
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
In the steady state Telmisartan 80mg & S-amlodipine 5mg T1/2
T1/2=Observed terminal elimination half-life
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Number of Participants with Adverse Events
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* Evaluated safety parameters included: Physical examination, vital sign, Laboratory test, ECG * Adverse event monitoring
Time frame: From 1day to 22 days