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This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: T - R- R | Experimental |
| |
| Treatment group B: R -T - R | Experimental |
| |
| Treatment group C: R- R-T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine Tablet | Drug | Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation) |
|
| 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 plasma 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 People's Hospital Of Liaoning Province | Shenyang | Liaoning | 110016 | China |
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| The number of volunteers with adverse events as a measure of safety and tolerability |
| up to Day 26 |