A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (6 days) ascending dose (20mg QD, 40mg QD, 20mg Bid) administrationof Anaprazole in healthy Chinese subjects. 36 subjects, 12 subjects for each dose group. In each dose group, 10 subjects take anaprazole, 2 subjects take placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.
Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.
Number of subjects with adverse events and serious adverse events as assessed by CTCAE v5.0
All adverse events will be monitored in each subject
Time frame: From signing informed consent to study completion, 15 days after fist dose administration
AUC of anaprazole (parent drug, KBP-3571) and its enantiomer(KBP-3570)and its major metabolites
AUC is area under the plasma concentration-time curve
Time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6
Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer(KBP-3570)and its major metabolites
Cmax is the peak plasma concentration
Time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6
Tmax of anaprazole (parent drug, KBP-3571) and its enantiomer(KBP-3570)and its major metabolites
Tmax is the time to peak plasma concentration
Time frame: 10 minutes pre-dose and 1.5、2、2.5、3、3.5、4、4.5、5、6、7、8、10、12、15、24 hours post-dose of Day 0 and Day 6
Time percentage of gastric pH value>3 in 24 hours gastric pH monitoring post dose at day 6
Time percentage gastric pH value\>3 is duration (hours) of gastric pH value\>3 divided to 24 hours
Time frame: 24 hours post-dose at day 6
Time percentage of gastric pH value>4 in 24 hours gastric pH monitoring post dose at day 6
Time percentage gastric pH value\>4 is duration (hours) of gastric pH value\>3 divided to 24 hours
Time frame: 24 hours post-dose at day 6
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