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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
single dose, oral administration 30 minutes after breakfast with high fat food.
single dose, oral administration before breakfast.
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
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
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
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