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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 (7 days) ascending dose (60mg QD, 80mg QD, 100mg Qd) administrationof Anaprazole in healthy Chinese subjects. 45 subjects, 15 subjects for each dose group. In each dose group, 10 subjects take investigational drug (anaprazole), 2 subjects take active comparatory drug (rabeprazole), 3 subjects take placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaprazole Sodium enteric-coated tablet | Experimental | "Multiple ascendinng dose, anaprazole 60mg QD(60mg QD group), 80mg QD(80mg QD group), 100mg QD(100mg QD group) , 7 days, fasting oral administration. " |
|
| Placebo | Placebo Comparator | Multiple dose, 1 tablet QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration. |
|
| Active controlled (rabeprazole) | Active Comparator | Multiple dose, rabeprazole 20mg QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anaprazole Sodium enteric-coated tablet | Drug | Multiple ascendinng dose, anaprazole 60mg QD(60mg QD group), 80mg QD(80mg QD group), 100mg QD(100mg QD group) , 7 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 at 14 days after fist dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100039 | China |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Multiple dose, 1 tablet QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration. |
|
| Active controlled (rabeprazole) | Drug | Multiple dose, rabeprazole 20mg QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration. |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |