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The study is being conduct to evaluate fluconazole effect of on SHR2554 in condition of single-canter, open-label, single-dose in healthy subjects. To explore the SHR2554 pharmacokinetics change under use of fluconazole and insure the safety with SHR2554 combined with fluconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR2554+ Fluconazole Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554 Tablets | Drug | SHR2554 Tablets+ Fluconazole Capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of SHR2554: Cmax | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: AUC0-t | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: AUC0-∞ | day 1 to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of SHR2554: Tmax | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: t1/2 | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: CL/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Single-center, open-label, single-dose, self-control
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| Fluconazole Capsules |
| Drug |
SHR2554 Tablets+ Fluconazole Capsules |
|
| day 1 to day 10 |
| Pharmacokinetic parameters of SHR2554: Vz/F | day 1 to day 10 |
| The incidence and severity of adverse events/serious adverse events | from ICF signing date to approximate day 18 |