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To assess the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers in Fasting State or Following a High Fat Meal
This is a single center, randomized, open label, single dose, two periods crossover study in healthy male volunteers. The volunteers will be randomly distributed into two groups (fasted-fed and fed-fasted groups). Any volunteer will be administrated once in each treatment period, the interval time of two treatment periods is 22 days (the interval time is no longer than 30 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted AST2818 tablets following a period of fasting | Experimental |
| |
| High-fat meal AST2818 tablets following a high-fat meal | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AST2818 Tablets | Drug | AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of AST2818 | Pharmacokinetics of AST2818 by assessment of maximum plasma AST2818 concentration. | Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. |
| AUC(0-t) of AST2818 | Pharmacokinetics of AST2818 by assessment of area under the plasma concentration time curve from zero to appointed time | Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. |
| Tmax of AST2818 | Pharmacokinetics of AST2818 by assessment of time to Cmax. | Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of AST5902 | Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of maximum plasma AST5902 concentration. | Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Tumor Hospital | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| C000705711 | aflutinib |
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| AST2818 Tablets | Drug | AST2818 Tablets: Period 1 allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. Period 2 fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once)and 4 hours after dosing on day 1. |
|
| AUC(0-t) of AST5902 |
Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of area under the plasma |
| Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. |
| Tmax of AST5902 | Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of time to Cmax. | Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. |