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drugset / Trial / NCT04048811

A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients

NCT04048811 ↗

Phase 2 Completed 46 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-12-09
Primary completion
2020-05-23
Completion
2020-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 1 mg/kg —
Comparator Propofol Small molecule 5 mg/kg —

Indications

No indication recorded.