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The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhibitor group | Experimental | Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day. |
|
| Inducer group | Experimental |
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib Hydrochloride Tablets | Drug | Oral Jaktinib 100 mg for 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration | Up to 32 Days |
| AUC | Area under the plasma concentration versus time curve (AUC) of Jaktinib | Up to 32 Days |
| Adverse Events | Number of Participants With treatment-related Adverse Events and Serious Adverse Events | Up to 32 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China |
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| Itraconazole capsule | Drug | Oral Itraconazole 200 mg for 9 day |
|
|
| Rifampicin Capsules | Drug | Oral Rifampicin 600 mg for 11 day |
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|
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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