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This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Cycle1 Day 1:fasting;Cycle2 Day 1:high-fat meal;Cycle3 Day 1:low-fat meal |
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| Arm B | Experimental | Cycle1 Day 1:high-fat meal;Cycle2 Day 1:low-fat meal;Cycle3 Day 1:fasting |
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| Arm C | Experimental | Cycle1 Day 1:low-fat meal;Cycle2 Day 1:fasting;Cycle3 Day 1:high-fat meal |
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| Arm D | Experimental | Cycle1 Day 1:fasting;Cycle2 Day 1:low-fat meal;Cycle3 Day 1:high-fat meal |
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| Arm E | Experimental | Cycle1 Day 1:high-fat meal;Cycle2 Day 1:fasting;Cycle3 Day 1:low-fat meal |
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| Arm F | Experimental | Cycle1 Day 1:low-fat meal;Cycle2 Day 1:high-fat meal;Cycle3 Day 1:fasting |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XZP-3287 | Drug | Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast |
| Measure | Description | Time Frame |
|---|---|---|
| Primary PK Endpoints | Cmax | day 1~day 21 |
| Primary PK Endpoints | AUC0-∞ | day 1~day 21 |
| Primary PK Endpoints | AUC0-t | day 1~day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary PK measures | Tmax | day 1~day 21 |
| Secondary PK measures | T1/2 | day 1~day 21 |
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Inclusion Criteria:
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuilan Xiao | Contact | 0086-13699167610 | xiaocuilan@xuanzhubio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
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| XZP-3287 | Drug | Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast |
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| XZP-3287 | Drug | Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast |
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| XZP-3287 | Drug | Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast |
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| XZP-3287 | Drug | Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast |
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| XZP-3287 | Drug | Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast |
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| Secondary PK measures | CL/F | day 1~day 21 |
| Secondary PK measures | Vz/F | day 1~day 21 |
| Safety and tolerability | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 | Up to 14 days after last dose |