Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
NCT05614544 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2023-10-13
Summary
Part 1: To determine the doses of IV HSK3486 and propofol for use in Part 2, the abuse potential part of the study.
Part 2: To evaluate the abuse potential of HSK3486 compared with propofol when administered IV to healthy nondependent, recreational CNS depressant drug users.
Conditions
- General Anesthesia
Interventions
- DRUG
-
HSK3486
HSK3486 for induction of general anesthesia
- DRUG
-
Propofol
Propofol for induction of general anesthesia
- DRUG
-
Intralipid
Sponsors & Collaborators
-
Haisco-USA Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-16
- Primary Completion
- 2023-10-03
- Completion
- 2023-10-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia
NCT04511728 ·Status: COMPLETED ·Phase: PHASE3
-
Neural and Antidepressant Effects of Propofol
NCT03684447 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients
NCT04048811 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
NCT00848991 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP
NCT01900938 ·Status: UNKNOWN ·Phase: NA
-
Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Healthy Volunteers
NCT00321360 ·Status: COMPLETED ·Phase: PHASE4
-
Minimal Effective Concentration of Lidocaine in Propofol Lidocaine Mixture for Relief of Pain on Propofol Injection
NCT05165303 ·Status: UNKNOWN ·Phase: PHASE4
-
Fospropofol for Sedation During Elective Awake Intubation
NCT01289483 ·Status: WITHDRAWN ·Phase: NA
-
Application of the Propofol Precise Infusion Model
NCT05158426 ·Status: COMPLETED
-
EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia
NCT01543633 ·Status: COMPLETED ·Phase: NA
-
Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia.
NCT06651749 ·Status: RECRUITING ·Phase: NA
-
Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery
NCT05158998 ·Status: UNKNOWN ·Phase: PHASE4
-
Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures
NCT01835340 ·Status: COMPLETED ·Phase: NA
-
Simultaneous Injection of Propofol and Rocuronium in Inducing General Anesthesia
NCT03270696 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate the Differences in Pharmadynamics, Pharmacokinetics, and Safety Between Ciprofol and Propofol
NCT04294056 ·Status: COMPLETED ·Phase: PHASE1
-
Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol
NCT02173340 ·Status: COMPLETED
-
Use of Subanesthetic Dose Propofol Before Extubation
NCT07276633 ·Status: COMPLETED ·Phase: NA
-
A Study to Assess the Efficacy and Safety of Fospropofol Disodium
NCT01271569 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients
NCT02147678 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication
NCT01976845 ·Status: COMPLETED ·Phase: PHASE4
-
The Hypotensive Effect of Propofol: an Observational Study
NCT01508351 ·Status: COMPLETED
-
Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol
NCT04520503 ·Status: COMPLETED
-
Effect of Affective Content on Drug Induced Amnesia of Episodic Memory
NCT00142493 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns
NCT04345926 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery
NCT05664386 ·Status: RECRUITING ·Phase: PHASE4