This study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of \[14C\]HSK3486, so as to characterize the drug's general pharmacokinetics and safety in humans and provide supportive data for reasonable use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
The subjects will receive an intravenous injection of 0.8 μCi/0.4 mg/kg of \[14C\]HSK3486 emulsion injection (i.e., a subject with the body weight of 60 kg is administered with a radiation dose of 48 μCi).
the First Affilicated Hospital of Soochow University
Suzhou, China
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 through 168 hours after administration
Maximum Plasma Concentration [Cmax] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: From the start of administration through 168 hours after administration
Time to plasma peak concentration[Tmax] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: From the start of administration through 168 hours after administration
Clearance half-life[t1/2] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: From the start of administration through 168 hours after administration
Area Under the Curve [AUC] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Time frame: From the start of administration through 168 hours after administration
The metabolite analysis of [14C]HSK3486 in human body
Pharmacokinetic Measures
Time frame: from the start of administration through 168 hours after administration
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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 168h after drug administration)
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 168h 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 168h 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 168h 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 168h 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 168h 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 168h 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 168h 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 168h 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 168h 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 168h 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 168h 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 168h after drug administration)