NCT04054063

A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects

An Open Label, Single-Center, Single Dose Combination of HSK3486 and Etomidate Intravenous Bolus Injection to Determine the Safety, Pharmacodynamics and Pharmacokinetics for Induction of Anesthesia in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety profile including pain on injection, hypotension, tachycardia or bradycardia effects (HSK3486), and involuntary muscle movements, nausea and vomiting potential and adrenal suppression (etomidate). All subjects will be administered HSK3486 plus etomidate. Subjects will be confined to the study unit from the evening of Day -1 until the morning of Day 2, then will be required to return for a follow up visit on Day 7. Intensive PD, PK, safety and tolerability and assessments will be performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

Conditions

• General Anesthetic
• Sedation

Interventions

Type	Name	Description
DRUG	HSK3486+ etomidate

Timeline

• Start date: 2016-11-30
• Primary completion: 2016-12-21
• Completion: 2017-06-28
• First posted: 2019-08-13
• Last updated: 2019-08-13