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The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Period 1: Subjects received HDM1002 table (200 mg×1)in fasted state; Period 2: Subjects received HDM1002 tables (100 mg×2)in fasted state; Period 3: Subjects received HDM1002 table (200 mg×1)in fed state. |
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| Cohort 2 | Experimental | Period 1: Subjects received HDM1002 tables (100 mg×2)in fasted state; Period 2: Subjects received HDM1002 table (200 mg×1)in fed state; Period 3: Subjects received HDM1002 table (200 mg×1)in fasted state. |
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| Cohort 3 | Experimental | Period 1: Subjects received HDM1002 table (200 mg×1)in fed state; Period 2: Subjects received HDM1002 table (200 mg×1)in fasted state; Period 3: Subjects received HDM1002 tables (100 mg×2)in fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1002 | Drug | Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC[0-∞] | Area under the curve from time 0 hour to ∞ | Day1-Day17 |
| AUC[0-t] | Area under the curve from time 0 to t hour | Day1-Day17 |
| Cmax | Maximum observed concentration | Day1-Day17 |
| Tmax | Time to maximum plasma concentration | Day1-Day17 |
| t1/2 | Half life | Day1-Day17 |
| CL/F | Apparent Clearance | Day1-Day17 |
| Vz/F | Apparent volume of distribution | Day1-Day17 |
| F | Relative Bioavailability | Day1-Day17 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Number of subjects reporting AEs | Day1-Day17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang | Contact | +86-18367124548 | nancywangying@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
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