drugset / Trial / NCT03745625

A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486

NCT03745625

Phase 1 Completed 16 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd
RandomizedCrossoverOpen-labelTreatment

Summary

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 after an initial dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.

Timeline

Start
2019-01-09
Primary completion
2019-07-02
Completion
2019-08-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.35 mg/kg Intravenous
Subject Cipepofol Small molecule 0.4 mg/kg Intravenous
Comparator Propofol Small molecule 0.4 mg/kg Intravenous
Comparator Propofol Small molecule 1.75 mg/kg Intravenous

Indications

No indication recorded.