A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Kyungpook National University Hospital
Daegu, South Korea
AUCtau
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
Integrated gastric acidity(%Decrease form baseline)
Evaluation PD after multiple dose
Time frame: 4 times from Day -1 to Day 17
Cmax
Evaluation PK after single dose
Time frame: Day 1
AUClast
Evaluation PK after single dose
Time frame: Day 1
AUCinf
Evaluation PK after single dose
Time frame: Day 1
Tmax
Evaluation PK after single dose
Time frame: Day 1
t1/2
Evaluation PK after single dose
Time frame: Day 1
CL/F
Evaluation PK after single dose
Time frame: Day 1
Vd/F
Evaluation PK after single dose
Time frame: Day 1
Cmax,ss
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
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Cmin,ss
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
AUCinf
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
Tmax,ss
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
t1/2
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
CLss/F
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
Vdss/F
Evaluation PK after multiple dose
Time frame: From Day 1 up to Day 17
Integrated gastric acidity(Variations form baseline)
Evaluation PD after multiple dose
Time frame: 4 times from Day -1 to Day 17
Percentage of time to maintain gastric pH 4.0 or higher
Evaluation PD after multiple dose
Time frame: 4 times from Day -1 to Day 17