A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
Daily oral administration of 1 tablet under fasting conditions for 7 days
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
Korea University Anam Hospital
Seoul, South Korea
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28
Cmax,ss(Maximum plasma concentration of the drug at steady state)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28
Cmin,ss(Minimum concentration of the drug in plasma at steady state)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28
Tmax,ss(Time to maximum plasma concentration at steady state)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28
t1/2(Terminal elimination half-life)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28
CLss/F(Apparent total body clearance of the drug from plasma at steady state)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28
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Vd,ss/F(Apparent volume of distribution at steady state)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28
PTF(Peak-to-trough fluctuation)
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Time frame: 0(predose)~24 hours at Day7 and Day28