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The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions. The secondary objective of the study is to evaluate the safety of hetrombopag olamine in healthy Chinese adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence #1 | Other | 29 of 58 subjects were given single oral dose of early phase hetrombopag olamine formulation in period 1 and late phase formulation in period 2 |
|
| Treatment sequence #2 | Other | 29 of 58 subjects were given single oral dose of late phase hetrombopag olamine formulation in period 1 and early phase formulation in period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag | Drug | Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | 0-120 hours post dose | |
| Area Under the plasma concentration vs time curve (AUC0-120). | 0-120 hours post dose | |
| area under the blood concentration vs time curve (AUC0-inf). | 0-infinity |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) | 0-120 hours post dose | |
| Half-life Associated With the Terminal Slope (t½) | 0-120 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| C000614661 | hetrombopag |
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