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The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Hemay022 Period 1, Fasted control → Period 2, Fed control |
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| Arm B | Experimental | Hemay022 Period 1, Fed control → Period 2, Fasted control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay022 | Drug | Participants will receive a single oral dose of Hemay022 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration for Hemay022 | Day 1: 0-48 hours; Day 8: 0-48 hours |
| Tmax | Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Hemay022 | Day 1: 0-48 hours; Day 8: 0-48 hours |
| AUC0-t | AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Hemay022 | Day 1: 0-48 hours; Day 8: 0-48 hours |
| AUC0-∞ | Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for Hemay022 | Day 1: 0-48 hours; Day 8: 0-48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingxue Lv | Contact | +86-22-24929667 | lvyingxue@hemay.com.cn | |
| Weiyong Li | Contact | +86-27-85726685 | 2621239868@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | China |
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| Hemay022 | Drug | Participants will receive a single oral dose of Hemay022 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods. |
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