This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.
27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Maximum observed plasma concentration (Cmax) of Sulfatinib
Maximum observed concentration, occurring at Tmax.
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
The time to Cmax (peak time, Tmax) of Sulfatinib
The time at which maximum plasma concentration (Cmax) is observed.
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Half-life (t1/2) of Sulfatinib
The time required for the concentration of the drug to reach half of its original value.
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Relative Bioavailability
This term represents the relationship between the bioavailability of a substance in two different media.
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Adverse Event (AE) monitoring of Sulfatinib
AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters.
Time frame: Measured from the date signed ICF to within 14 days after the last dose
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