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A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaprazole Sodium enteric-coated tablet | Experimental | Single ascendinng dose (2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg), fasting oral administration. |
|
| Placebo | Placebo Comparator | single dose, fasting oral administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anaprazole Sodium | Drug | 2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg,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, 8 days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo | Drug | single dose, fasting oral administration |
|