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This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hetrombopag Olamine A | Active Comparator | health subjects received 7.5 mg Hetrombopag Olamine while fasting. |
|
| Hetrombopag Olamine B | Active Comparator | health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine |
|
| Hetrombopag Olamine C | Active Comparator | health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine | Drug | 7.5mg in each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | from baseline up to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group | |
| Area under the plasma concentration versus time curve (AUC) | pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third xiangya hospital Hospital,of central south university | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |