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This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hetrombopag 7.5mg fasted to fed | Experimental | Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11. |
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| hetrombopag 7.5mg fed to fasted | Experimental | Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) of hetrombopag | Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state | 0h-120h |
| The area under the plasma concentration-time curve (AUC) of hetrombopag | AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state | 0h-120h |
| The accumulative excretion rate of hetrombopag and its metabolites in urine and feces | 0h-120h |
| Measure | Description | Time Frame |
|---|---|---|
| The change of platelet count | On day 2, 4, 6, 8,12, 14 and 16 | |
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Hospital, Sichuan University | Chengdu | Sichuan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33109386 | Derived | Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L. Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers. Clin Ther. 2020 Dec;42(12):2280-2288. doi: 10.1016/j.clinthera.2020.10.002. Epub 2020 Oct 24. |
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