Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)
To evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 20mg and Nexium tab 20mg and the effects of food influence the PK/PD of YYD601 20mg in a healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)
Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori
Kyungpook national university hospital
Daegu, South Korea
Cmax
Cmax after single administration and repeated administration
Time frame: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
AUC
AUC after single administration and repeated administration
Time frame: Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day
AUC
AUC after single administration and repeated administration
Time frame: pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day
Tmax
Tmax after single administration and repeated administration
Time frame: pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day
t1/2
t1/2 after single administration and repeated administration
Time frame: pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day
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