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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaprazole Sodium enteric-coated tablet | Experimental | "Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration. |
|
| Placebo | Placebo Comparator | Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anaprazole Sodium enteric-coated tablet | Drug | Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From signing informed consent to study completion, 15 days after fist dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo | Drug | Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration. |
|
Cmax is the peak plasma concentration |
| 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 | 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 | 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 | 24 hours post-dose at day 6 |