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This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.
Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A(Dosing in the fasted state followed by fed dosing) | Experimental | Dosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods. |
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| Group B(Dosing in the fed state followed by fasted dosing) | Experimental | Dosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-16350 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| AUC0-t | Area under the concentration-time curve from time 0 to time t | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| AUC0-∞ | Area under the concentration-time curve from time 0 to infinity | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to reach maximum observed plasma concentration | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| t1/2 | Half-life time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haibin Yu, Ph.D | Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
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| from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| λz | Elimination rate constant | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| tlag | Lag Time | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| AUC %Extrap | Percentage of AUCinf due to extrapolation from Tlast to infinity | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| CL/F | Apparent Oral Clearance | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| V/F | Apparent Volume of Distribution | from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose |
| Characterize the safety of BPI-16350 | Number of subjects with treatment related adverse events | from Day 1 to Day 23 |