The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the pharmacokinetic properties of atorvastatin.
healthy subjects are administrated single-dose over the period Ⅰand Ⅱ(Crossover) of telmisartan/s-amlodipine, atorvastatin and atorvastatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
* 3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one), * oral intake, once in a period * over the period Ⅰ\&Ⅱ(crossover)
* 1 Tablet (atorvastatin 40mg), * oral intake, once in a period * over the period Ⅰ\&Ⅱ(crossover)
Severance Hospital
Seoul, South Korea
In the steady state atorvastatin 40mg AUClast
AUClast: Area under the plasma concentration time curve from zero time until the last measurable concentration.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg Cmax
Cmax: maximum plasma drug concentration
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg AUCinf
AUCinf: Area Under the Concentration time curve from time zero to infinity
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg Tmax
Tmax: Time to Cmax
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg t1/2
t1/2: Observed terminal elimination half-life
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
Number of participants with adverse events
* Evaluated safety parameters included: physical examination, vital sign, laboratory test, ECG * Adverse event monitoring
Time frame: From 1day to 17days
In the steady state Orthohydroxy-atorvastatin AUClast
AUClast: Area under the plasma concentration time curve from zero time until the last measurable concentration.
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
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In the steady state Orthohydroxy-atorvastatin Cmax
Cmax: maximum plasma drug concentration
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin AUCinf
AUCinf: Area Under the Concentration time curve from time zero to infinity
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin Tmax
Tmax: Time to Cmax
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin t1/2
t1/2: Observed terminal elimination half-life
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose