This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous \[14C\]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and provide a reference for reasonable use of this drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The first 2 subjects will receive an intravenous injection of 0.4 mg/kg of HSK3486 emulsion injection (containing \[14C\] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg, i.e. a subject with the body weight of 60 kg is administered with a radiation dose of 300 nCi). The radiation dose for subsequent subjects can be adjusted based on the results of the first 2 subjects.
Percentage of cumulative drug excretion of [14C]HSK3486 on biological specimens(urine and faeces) accounting for total radiation drug dose
Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of \[14C\]HSK3486,calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces).
Time frame: from the start of administration to 96 hours after administration
Maximum Plasma Concentration [Cmax] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: from the start of administration to 96 hours after administration
Time to plasma peak concentration[Tmax] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: from the start of administration to 96 hours after administration
Clearance half-life[t1/2] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: from the start of administration to 96 hours after administration
Area Under the Curve [AUC] of 14C radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: from the start of administration to 96 hours after administration
Number of patients with adverse events and serious adverse events
Safety Measures
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
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Blood routine test
Observe the changes of blood routine test during the whole trial
Time frame: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Urine routine test
Observe the changes of urine routine test during the whole trial
Time frame: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Blood biochemical examination
Observe the changes of Blood biochemical examination during the whole trial
Time frame: At the time of subject is being screened and at the end of study( nearly 96h after drug administration)
Blood pressure
Observe the changes of blood pressure during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Heart rate or pulse
Observe the changes of heart rate or pulse during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Respiratory rate or blood oxygen saturation
Observe the changes of respiratory rate or blood oxygen saturation during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
Heart rate of electrocardiogram
Observe the changes of heart rate of electrocardiogram during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
RR interval of electrocardiogram
Observe the changes of RR interval of electrocardiogram during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QT interval of electrocardiogram
Observe the changes of QT interval of electrocardiogram during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QTcF interval of electrocardiogram
Observe the changes of QTcF interval of electrocardiogram during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
PR interval of electrocardiogram
Observe the changes of PR interval of electrocardiogram during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)
QRS interval of electrocardiogram
Observe the changes of QRS interval of electrocardiogram during the whole trial
Time frame: From the time the subject is being screened to the end of the trial( nearly 96h after drug administration)