A dose block-randomized, open-label, parallel clinical trial
This study to evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 and Nexium tab and the effects of food influence the PK/PD of YYD601 in healthy adult male.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Kyungpook national university hospital
Daegu, South Korea
half-life
Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) half-life(after single dose), (after repeated dose)
Time frame: Evaluate the before/after treatment period(5 days per phase)
Tmax
Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Tmax(after singlidose), Tmax.ss(after repeated dose)
Time frame: Evaluate the before/after treatment period(5 days per phase)
Concentration
Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Cmax(after singlidose), Cmax.ss(after repeated dose) Cmin.ss(after single dose),Cmin.ss(after single dose)
Time frame: Evaluate the before/after treatment period(5 days per phase)
AUC
Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) AUClast(after singlidose), AUCt(after repeated dose) AUCinf(after single dose), AUCinf(after repeated dose)
Time frame: Evaluate the before/after treatment period(5 days per phase)
Percent of pH>4 duration time
pH\>4 duration time
Time frame: Evaluate the before/after treatment period(5 days per phase)
% change in serum gastrin level
serum gastrin level
Time frame: Evaluate the before/after treatment period(5 days per phase)
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Nexium