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This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The DDI of ZSP1273 ,Warfarin and Midazolam | Experimental | Warfarin and midazolam will be co-administered alone and in combination with ZSP1273. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSP1273 | Drug | Drug Warfarin oral Drug midazolam oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| S-warfarin Maximum Plasma Concentration [Cmax] | To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin | Day1 to Day28 |
| Midazolam Maximum Plasma Concentration [Cmax] | To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam | Day1 to Day28 |
| S-warfarin Area under the curve[AUC0-inf] | To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin | Day1 to Day28 |
| Midazolam Area under the curve[AUC0-inf] | To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam | Day1 to Day28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events | To assess the safety and tolerability of ZSP1273 following single and multiple-dose administration with and without midazolamin+S-warfarin in healthy participates | Day1 to Day28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
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| ID | Term |
|---|---|
| C000721066 | ZSP1273 |
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