Clinical Trials Logo
  1. Home
  2. Safety Issues
  3. NCT04113343

Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

Safety Issues Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial Description

Evaluating the potential for additive or synergistic effects of alcohol when coadministered with remimazolam. Female subjects were selected because they represent the population at greatest risk for victimization in drug-facilitated sexual assault. In addition, females have a slower ethanol metabolism, therefore, the effects of remimazolam, if coadministered with alcohol, may last longer. Hence, this population represents the worst-case scenario in evaluating the risk of remimazolam misuse in drug-facilitated assault. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04113343
Study type Interventional
Source Paion UK Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 30, 2017
Completion date August 9, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT04485481 - Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers Phase 1
Completed NCT03473236 - Phase 1A Safety Trial of Inhaled PK10571 (GB002) Phase 1
Not yet recruiting NCT03683953 - The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells Phase 1
Recruiting NCT05546567 - NOPARK Open Label Extension Study N/A
Recruiting NCT05413226 - Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility N/A
Recruiting NCT05112159 - Study of IPG1094 in Healthy Participants Phase 1
Completed NCT04689035 - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144 Phase 1
Completed NCT04335045 - Phase I Study of PH100 (Ecklonia Cava Phlorotannins) Phase 1
Completed NCT05037227 - Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Recruiting NCT05517291 - DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease N/A
Enrolling by invitation NCT06446778 - Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
Recruiting NCT04573049 - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Phase 4
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Completed NCT04188821 - Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander N/A
Completed NCT03667430 - Safety Evaluation of Porous Silica in Men N/A
Completed NCT04499482 - Safety and Tolerability of Soy Fiber N/A
Completed NCT03141905 - Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease N/A
Completed NCT05244161 - A Quasi-experimental Evaluation of the Malezi Program in Tanzania N/A
Recruiting NCT03791372 - Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy Phase 1
Not yet recruiting NCT04774900 - Standardization of Ambulance Equipment