A Study Evaluating the Mass Balance of [14C]HSK3486 Emulsion Injection in Healthy Adults.

NCT03751956 ↗

Phase 1 Completed 6 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd

NaSingle-groupOpen-labelTreatment

Summary

This study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of \[14C\]HSK3486, so as to characterize the drug's general pharmacokinetics and safety in humans and provide supportive data for reasonable use.

Timeline

Start: 2019-01-06
Primary completion: 2019-02-28
Completion: 2019-03-10

Publications

Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cipepofol	Small molecule	0.4 mg/kg	Intravenous

Indications

No indication recorded.