Clinical trials: Remimazolam
Healthy
A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers
The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
- Trial name
- NCT01970072
- Testing
- Remimazolam Tosylate, Midazolam
- Where
- China
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pediatric ALL
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
- Trial name
- NCT04851717
- Testing
- Remimazolam
- Where
- 8 sites in United States, Denmark
- Volunteers
- 100 people
- Sponsor
- Acacia Pharma Ltd
Sedation
Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy
The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.
- Trial name
- NCT03779061
- Testing
- Remimazolam Tosilate, Propofol
- Where
- China
- Volunteers
- 388 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Anesthesia
A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers
The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
- Trial name
- NCT03444480
- Testing
- Remimazolam Tosylate
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Sedation
Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy
The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.
- Trial name
- NCT01145222
- Testing
- A. CNS 7056, B. CNS 7056, C. CNS 7056
- Where
- 9 sites in United States
- Volunteers
- 162 people
- Sponsor
- Paion UK Ltd.
Sedation
A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
- Trial name
- NCT04400201
- Testing
- Remimazolam Tosilate, Propofol
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Long-Eye Surgeries
Remifentanil and Remimazolam to Limit Patient Movement
Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients…
- Trial name
- NCT06583811
- Testing
- Remifentanil
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Egymedicalpedia
Sedation in the ICU
A Study of Remimazolam Tosilate for Sedation in the ICU
The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for…
- Trial name
- NCT05152303
- Testing
- Remimazolam Tosilate
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Bronchoscopy
A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.
- Trial name
- NCT02296892
- Testing
- Remimazolam, Midazolam
- Where
- 14 sites in United States
- Volunteers
- 446 people
- Sponsor
- Paion UK Ltd.
Anesthesia
Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil
This trial is designed to quantify the pharmacodynamic (PD) and pharmacokinetic (PK) interaction(s) between an anaesthetic drug (remimazolam) and an opioid (remifentanil).
- Trial name
- NCT04670471
- Testing
- Remimazolam, Remifentanil
- Where
- Netherlands
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Procedural Sedation, Endoscopy
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
- Trial name
- NCT00869440
- Testing
- CNS 7056, Midazolam
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Paion UK Ltd.
Anesthesia, Intravenous
Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery
A phase III confirmatory trial evaluating the efficacy and safety of remimazolam (CNS7056) compared to propofol for intravenous anesthesia during elective surgery in ASA Class III/IV patients.
- Trial name
- NCT03661489
- Testing
- Remimazolam, Propofol
- Where
- Germany
- Volunteers
- 469 people
- Sponsor
- Paion UK Ltd.
Safety Issues
Oral Remimazolam With and Without Alcohol in Healthy Female Subjects
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects
- Trial name
- NCT04113343
- Testing
- Remimazolam, Alcohol
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Procedural Sedation
A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability
A prospective dose escalation, nine period cross-over trial assessing the safety, pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam when administered intranasally as powder and solution in…
- Trial name
- NCT03329014
- Testing
- Remimazolam
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Abuse, Drug
Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users
A double-blind, randomized crossover study to assess the subjective abuse potential of intravenous remimazolam compared to midazolam and placebo in recreational CNS depressant users
- Trial name
- NCT04110535
- Testing
- Remimazolam, Midazolam, Saline
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Bioavailability
Absolute Oral Bioavailability of Remimazolam
A randomized, open-label, single-dose, 2-way crossover study to compare the relative bioavailability of orally administered remimazolam to an intravenous formulation in healthy volunteers
- Trial name
- NCT04113564
- Testing
- Remimazolam
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Local Anesthesia Assisted Sedation
A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation
To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.
- Trial name
- NCT05015361
- Testing
- Remimazolam Tosilate, Propofol Injection.
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
General Anesthesia and Bronchoscopy Sedation
A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all…
- Trial name
- NCT05549791
- Testing
- Remimazolam Tosilate for Injection
- Where
- China
- Volunteers
- 1,285 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
General Anesthesia
A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.
- Trial name
- NCT02406872
- Testing
- Remimazolam Tosilate, Propofol
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Anesthesia for Elective Surgery Patients
A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery
The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.
- Trial name
- NCT03921775
- Testing
- Remimazolam Tosilate, Propofol
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.