This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
Sequence 2: Orally take 600 mg rifampin once a day for 8 consecutive days in the morning on an empty stomach, followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.
Shanghai Public Health Clinical Center
Shanghai, China
Peak concentration (Cmax)
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Area under the concentration-time curve (AUC0-t, AUC0-∞)
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Terminal elimination half life (t1/2)
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Time to fully awake
Time frame: From the start of HSK3486 administration until the subjects is fully awake on day 1
MOAA/S(modified observer's assessment of alert /sedation)-time curve
Observe the change of modified observer's assessment of alert /sedation during the whole trial
Time frame: From the start of HSK3486 administration until the subjects is fully awake on day 1
BIS(bispectral index)-time curve
Observe the changes of bispectral index during the whole trial
Time frame: From the start of HSK3486 administration to 60 min after the start of administration on day 1
Blood pressure
Observe the changes of blood pressure during the whole trial
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Heart rate
Observe the changes of heart rate during the whole trial
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Respiratory rate or blood oxygen saturation
Observe the changes of respiratory rate or blood oxygen saturation during the whole trial
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Blood routine test
Observe the changes of blood routine test during the whole trial
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Urine routine test
Observe the changes of urine routine test during the whole trial
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Blood biochemical examination
Observe the changes of Blood biochemical examination during the whole trial
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
12-Electrocardiogram
Observe the changes of heart rate, RR interval, QT interval , QTcF interval , PR interval and QRS interval of electrocardiogram during the whole trial
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Number of patients with adverse events
Safety endpoits
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Concurrent medications
Safety endpoits
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1