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An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluconazole and Famitinib interaction | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole、Famitinib | Drug | Fluconazole, once daily on Days 12 to 24; Famitinib, once daily on Days 1 and 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) for famitinib | Day 1 to Day 25 | |
| Area under the concentration-time curve from time zero to time t (AUC0-t,) for famitinib | Day 1 to Day 25 | |
| Area under the concentration-time curve extrapolated to infinity (AUC0-∞.) for famitinib (if applicable) | Day 1 to Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed serum concentration (Tmax) for famitinib | Day 1 to Day 25 | |
| Time to elimination half-life (t1/2) for famitinib | Day 1 to Day 25 | |
| Apparent oral clearance (CL/F) for famitinib |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Fluconazole and famitinib interaction
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| Day 1 to Day 25 |
| Apparent Volume of Distribution (Vz/F) for famitinib | Day 1 to Day 25 |
| Tmax for famitinib metabolite SHR116637 | Day 1 to Day 25 |
| Cmax for famitinib metabolite SHR116637 | Day 1 to Day 25 |
| AUC0-t, for famitinib metabolite SHR116637 | Day 1 to Day 25 |
| AUC0-∞. for famitinib metabolite SHR116637(if applicable) | Day 1 to Day 25 |
| t1/2 for famitinib metabolite SHR116637 | Day 1 to Day 25 |
| The incidence and severity of adverse events/serious adverse events (based on NCI-CTC AE 5.0) | Day 1 to Day 25 |