The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new and old formulations after oral dose under fasted condition on healthy Chinese subjects. The secondary objective is to evaluate the safety after famitinib malate capsules oral dose on healthy Chinese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
TR group: The first period,the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout;The second period,the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h. RT group: The first period,the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout;The second period,the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h.
Xuanwu Hospital Beijing, Capital Medical University
Beijing, Beijing Municipality, China
Pharmacokinetics parameter: Cmax
Peak plasma concentration (Cmax)
Time frame: through study completion, an average of 30 days
Pharmacokinetics parameter: AUC
Area under the plasma concentration versus time curve(AUC)
Time frame: through study completion, an average of 30 days
Pharmacokinetics parameter: Tmax
Time of maximum observed concentration (Tmax)
Time frame: through study completion, an average of 30 days
Pharmacokinetics parameter: t1/2
Half time (t1/2)
Time frame: through study completion, an average of 30 days
Pharmacokinetics parameter: λz
First order elimination rate constant (λz)
Time frame: through study completion, an average of 30 days
The number of participants with treatment-related adverse events assessed by CTCAE V5.0
An adverse event is any untoward medical occurrence in the subjects or clinical study participants.
Time frame: through study completion, an average of 30 days
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