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To evaluate the effect of itraconazole/rifampicin on the pharmacokinetics of TQB3616 capsules.
To assess the safety of a single dose of oral TQB3616 capsules and in combination with itraconazole/rifampicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhibitor group | Experimental | Oral TQB3616 capsules 60 mg after a single meal on days 1 and 13; On days 10 to 21, itraconazole capsules 200mg were taken orally once a day for 12 days after meals. |
|
| Inducer group | Experimental | 180mg of TQB3616 capsules orally after a single meal on days 1 and 17; Oral administration of rifampicin capsules 600mg from day 10 to day 25 on the peritoneum once a day for 16 consecutive days, of which rifampicin capsules 600mg and TQB3616 capsules 180mg were taken at the same time after meals on the 17th day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3616 capsule + itraconazole | Drug | C2/4/6 inhibitors + CYP3A metabolic enzyme inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Maximum plasma drug concentration | Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration |
| Area under drug time curve (AUC0-t) | Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration. | Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration |
| Area under drug time curve (AUC0-∞) | Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. | Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | Incidence and severity of adverse events and serious adverse events, and abnormal laboratory examination indicators. | From before the first administration to 26 days after the administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laichun Lu | Contact | 138 8393 3701 | lulaicq@163.com |
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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 |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| TQB3616 capsule + rifampicin | Drug | C2/4/6 inhibitors + Non-specific cytochrome P450 enzyme inducer |
|
| 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 |