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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
Fluconazole, once daily on Days 12 to 24; Famitinib, once daily on Days 1 and 15
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Maximum observed serum concentration (Cmax) for famitinib
Time frame: Day 1 to Day 25
Area under the concentration-time curve from time zero to time t (AUC0-t,) for famitinib
Time frame: Day 1 to Day 25
Area under the concentration-time curve extrapolated to infinity (AUC0-∞.) for famitinib (if applicable)
Time frame: Day 1 to Day 25
Time to maximum observed serum concentration (Tmax) for famitinib
Time frame: Day 1 to Day 25
Time to elimination half-life (t1/2) for famitinib
Time frame: Day 1 to Day 25
Apparent oral clearance (CL/F) for famitinib
Time frame: Day 1 to Day 25
Apparent Volume of Distribution (Vz/F) for famitinib
Time frame: Day 1 to Day 25
Tmax for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
Cmax for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
AUC0-t, for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
AUC0-∞. for famitinib metabolite SHR116637(if applicable)
Time frame: Day 1 to Day 25
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t1/2 for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
The incidence and severity of adverse events/serious adverse events (based on NCI-CTC AE 5.0)
Time frame: Day 1 to Day 25