This is a clinical study to evaluate the bioequivalence of dasatinib tablet produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Sprycel® produced by Bristol Myers Squibb after single dose in healthy subjects, so as to provide reference for clinical evaluation and clinical medication; to observe the safety of the dasatinib tablet and the reference drug Sprycel® in healthy subjects under fasting and fed states.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Chia Tai Tianqing Pharmaceutical Group.
Sprycel Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Bristol Myers Squibb.
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Maximum (peak) plasma drug concentration (Cmax)
Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Area under the plasma concentration-time curve from time zero to time t is a Pharmacokinetic parameter
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
The area under the plasma concentration curve from 0 to infinity (AUC0-∞)
The area under the plasma concentration curve from 0 to infinity
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Time to maximum concentration (Tmax)
Time to reach maximum (peak) plasma concentration following drug administration
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Elimination half-life (t1/2)
The time required for the highest concentration of the drug in plasma to decrease by half
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Apparent end elimination rate constant (λz)
Terminal disposition rate constant/terminal rate constant
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
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Apparent volume of distribution (Vd/F)
Apparent volume of distribution after oral administration
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Apparent total body clearance (CL/F)
Apparent total clearance of the drug from plasma after oral administration
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Relative bioavailability
Bioavailability (systemic availability of the administered dose)
Time frame: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Adverse Event
Adverse events of subjects occured during the trial
Time frame: Up to day 11
Serious Adverse Event
Serious Adverse events of subjects occured during the trial
Time frame: Up to day 11
Body temperature
Monitor the body temperature of subjects and report abnormal body temperature
Time frame: Up to day 11
Pulse
Monitor the pulse of subjects and report abnormal pulse
Time frame: Up to day 11
Blood pressure
Monitor the blood pressure of subjects and report abnormal blood pressure
Time frame: Up to day 11
CTCAE v5.0
The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)
Time frame: Up to day 11
The Number of participants with abnormal laboratory examinations
laboratory examination, such as liver function, kidney function, coagulation function, blood routine, urine routine
Time frame: Up to day 11