A Phase 1 interventional study of HSK3486 and Placebo in Anesthesia, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects.
Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Abnormal 12-lead ECG at screening or baseline (any test abnormality), including any of the following:
Drug: HSK3486
Drug: Placebo
Drug: Moxifloxacin
0.4 mg/kg, IV bolus administration
Also known as: Ciprofol
IV bolus administration
0.4 g, Oral administration with 240 mL
ΔQTcI
The change-from-baseline in QTc interval, corrected for HR using the individual QT correction method (QTcI).
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period.
ΔHR, ΔQTcF, ΔPR, and ΔQRS
Change-from-baseline HR, QTcF, PR, and QRS intervals, which will be used as the dependent variable for calculation of model-derived ΔΔHR, ΔΔQTcF, ΔΔPR, and ΔΔQRS for the by-time point analysis, respectively.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period.
Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals
Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period.
AE and SAE
Incidence of AE and SAE
Time frame: Up to Day 18
Cmax
Maximum Observed Plasma Concentration
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period
AUClast
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration of HSK3486
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period
t1/2
Elimination Half-Life
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period
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Haisco Pharmaceutical Group Co., Ltd.