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This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole drug-durg interaction (DDI) | Experimental | Itraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8. |
|
| Rifampicin DDI | Experimental | Rifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3909 tablets | Drug | TQB3909 100mg/tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to reach maximum (peak) plasma concentration following drug administration. | Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10. |
| Maximum Plasma Concentration (Cmax) | The maximum observed plasma concentration of TQB3909 | Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10. |
| Elimination half-life (t1/2) | The time required for half of the drug to be eliminated from the plasma. | Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Incidence of adverse events (AEs) based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | Up to 12 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Hua, MD, PhD | Contact | 0519-68870002 | czyyphase1@163.com | |
| Weiying Gu, MD, PhD | Contact | 0519-68871092 | guweiying2001@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | 213004 | 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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| Itraconazole capsule | Drug | Itraconazole capsule is a strong inhibitor of CYP3A4. |
|
| Rifampicin capsule | Drug | Rifampicin capsule is a strong inducer of CYP3A4. |
|
| 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 |