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The primary objective of the study is to evaluate the effect of Itraconazole on pharmacokinetics of ZX-7101 in healthy Chinese adult subjects after oral administration of ZX-7101A tablets.
The secondary objective of the study is to evaluate the safety and tolerability of single dose of ZX-7101A orally in healthy subjects.
Evaluate the effect of Itraconazole on pharmacokinetics of pre-drug ZX-7101A in healthy Chinese adult subjects after oral administration of ZX-7101A tablets.
ZX-7101A tablets 40 mg once on Day 1 and Day 31, Itraconazole 200 mg once daily (QD) from Study Day 26 - 50
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZX-7101A and Itraconazole | Experimental | D1 and D31 Take ZX-7101A tablet 40mg (1 tablet, 40mg/ tablet),oral,fasting; D26-D50 Itraconazole capsule 200mg(2 capsules, 100mg/ capsule) ,oral in 30min after breakfast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX-7101A | Drug | Single dose of oral administration of ZX-7101A and Multiple dose of oral of Itraconazole Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of active metabolite ZX-7101after a single oral ZX-7101A tablet and combined with multiple oral itraconazole capsules in healthy Chinese adult subjects | Cmax | Day1-Day20, Day31-Day50 |
| PK parameters of active metabolite ZX-7101after a single oral ZX-7101A tablet and combined with multiple oral itraconazole capsules in healthy Chinese adult subjects | AUC0-t | Day1-Day20, Day31-Day50 |
| PK parameters of active metabolite ZX-7101after a single oral ZX-7101A tablet and combined with multiple oral itraconazole capsules in healthy Chinese adult subjects | AUC0-inf | Day1-Day20, Day31-Day50 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of AE | Rate of TEAE | Day1-Day20, Day31-Day50 |
| PK parameters of prodrug ZX-7101A | Cmax | Day1-Day20, Day31-Day50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| PK parameters of prodrug ZX-7101A | AUC0-t | Day1-Day20, Day31-Day50 |
| PK parameters of prodrug ZX-7101A | AUC0-inf | Day1-Day20, Day31-Day50 |
| PK parameters of ZX-7101 | Tmax | Day1-Day20, Day31-Day50 |
| PK parameters of ZX-7101 | CL/F | Day1-Day20, Day31-Day50 |
| D010879 |
| Piperazines |