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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 |
|---|---|---|---|
| High fat food oral administration | Experimental | Anaprazole 40mg, single dose, oral administration 30 minutes after breakfast with high fat food. |
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| Fasting oral administration | Experimental | Anaprazole 40mg, single dose, oral administration before breakfast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anaprazole | Drug | single dose, oral administration 30 minutes after breakfast with high fat food. |
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| 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 |
| Cmax of anaprazole (parent drug, KBP-3571) and its enantiomer(KBP-3570)and its major metabolites | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Anaprazole | Drug | single dose, oral administration before breakfast. |
|