A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
1 tablet administered before the breakfast during 7 days
1 tablet administered before the breakfast during 7 days
1 tablet administered before the breakfast during 7 days
Seoul National University Hospital
Seoul, South Korea
AUCtau,ss(Area under the plasma drug concentration-time curve)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Evaluation PD esomeprazole after multiple dose
Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
AUCtau(Area under the plasma drug concentration-time curve)
Evaluation PK esomeprazole after single dose
Time frame: Day1
Cmax(Maximum concentration of drug in plasma)
Evaluation PK esomeprazole after single dose
Time frame: Day1
Tmax(Time to maximum plasma concentration)
Evaluation PK esomeprazole after single dose
Time frame: Day1
t1/2(Terminal elimination half-life)
Evaluation PK esomeprazole after single dose
Time frame: Day1
CL/F(Apparent clearance)
Evaluation PK esomeprazole after single dose
Time frame: Day1
Vd/F(Apparent volume of distribution)
Evaluation PK esomeprazole after single dose
Time frame: Day1
Cmax,ss(Maximum concentration of drug in plasma at steady state)
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1 tablet administered before the breakfast during 7 days
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
Cav,ss(Average concentration of drug in plasma at steady state)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
Tmax,ss(Time to maximum plasma concentration at steady state)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
t1/2,ss(Terminal elimination half-life at steady state)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
CLss/F(Apparent Clearance at steady state)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
Vss/F(Apparent Volume of distribution at steady state)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
PTF(Peak trough fluctuation over one dosing interal at steady state)
Evaluation PK esomeprazole after multiple dose
Time frame: From Day 1 up to Day 29
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
Evaluation PD esomeprazole
Time frame: Day1 24hrs pH monitoring
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Evaluation PD esomeprazole
Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Evaluation PD esomeprazole
Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring