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This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D1:hetrombopag single dose,D11-D15:cyclosporine,D16 combination use of hetrombopag and cyclosporine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine Tabletï¼›Ciclosporin Soft Capsule | Drug | Drug: Hetrombopag Olamine Tablet Ciclosporin Soft Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak hetrombopag plasma concentration (Cmax) | 0-120 hours post dose | |
| Area Under the plasma hetrombopag concentration vs time curve (AUC0-120) | 0-120 hours post dose | |
| Area under the plasma hetrombopag 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 |
|---|---|---|---|---|---|---|
| West China Second University Hospital Ethics Committee | Chengdu | Sichuan | 610041 | China |
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| The number of volunteers with adverse events as a measure of safety and tolerability |
| up to Day 22 |