A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients
Status:
Completed
Trial end date:
2020-06-22
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, open-label, positive-controlled (propofol) phase II
clinical trial. The study plans to enroll approximately 46 eligible subjects. Among them, 40
subjects will be randomly assigned to HSK3486 treatment group (30 cases) and propofol control
group (10 cases) in a ratio of 3:1. The subjects will be enrolled competitively at all study
sites. Upon enrollment of the 40 subjects, 6 more subjects will be enrolled by West China
Hospital of Sichuan University. These 6 subjects will not be randomized, but will directly
enter into propofol induction + HSK3486 maintenance group for study.
Phase:
Phase 2
Details
Lead Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd Sichuan Haisco Pharmaceutical Group Co., Ltd.