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Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib and the safety of the combination therapy in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clifutinib | Experimental | On Day 1, subjects will receive a single dose of 40 mg Clifutinib |
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| Clifutinib and Itraconazole | Active Comparator | From Day 1 to Day 49, subjects will receive Itraconazole 200mg bid, and receive single dose of 40mg Clifutinib on Day 8 |
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| Clifutinib and Fluconazole | Active Comparator | From Day 1 to Day 49, subjects will receive Fluconazole 400mg qd, and receive single dose of 40mg Clifutinib on Day 8 |
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| Clifutinib and Efavirenz | Active Comparator | From Day 1 to Day 49, subjects will receive Efavirenz 600mg qd, and receive single dose of 40mg Clifutinib on Day 8 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clifutinib | Drug | The subjects are required to take Clifutinib on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants. | From Day1 to Day50 |
| AUC0-t | Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants. | From Day1 to Day50 |
| AUC0-∞ | Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants. | From Day1 to Day50 |
| %AUCex | Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants. | From Day1 to Day50 |
| Tmax | Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants. | From Day1 to Day50 |
| t1/2 | Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants. | From Day1 to Day50 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Frequency, type and severity of adverse events/serious adverse events. | From Day1 to Day50 |
| ECG(Electrocardiogram) | Evaluation parameters include heart rate, PR interval, QTcF and QRS interval, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao, Doctor | Contact | +86 0531-89268212 | zhao4wei2@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) | Jinan | Shandong | 250000 | China |
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Clifutinib,Itraconazole, Fluconazole, Efavirenz
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| Itraconazole | Drug | Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch. |
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| fluconazole | Drug | Take fluconazole on an empty stomach |
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| efavirenz | Drug | Take efavirenz on an empty stomach |
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| From Day1 to Day50 |
| Body temperature | Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group. | From Day1 to Day50 |
| Blood pressure | Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group. | From Day1 to Day50 |
| Pulse | Summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group. | From Day1 to Day50 |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D015725 | Fluconazole |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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