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This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted | Experimental | BPI-7711 following a period of fasting |
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| High-fat meal | Experimental | BPI-7711 following a high-fat meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-7711 | Drug | BPI-7711 180 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration | Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose |
| AUC(0-last) | Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint | Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongfang Yuan | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | 200025 | China |
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| ID | Term |
|---|---|
| C000728929 | rezivertinib |
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