Viewing Study NCT04670471



Ignite Creation Date: 2024-05-06 @ 3:34 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04670471
Status: COMPLETED
Last Update Posted: 2023-09-11
First Post: 2020-11-25

Brief Title: Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil
Sponsor: Paion UK Ltd
Organization: Paion UK Ltd

Study Overview

Official Title: Single-centre Randomised Prospective Open-label Three-period Phase 1 Clinical Trial for Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil
Status: COMPLETED
Status Verified Date: 2023-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This trial is designed to quantify the pharmacodynamic PD and pharmacokinetic PK interactions between an anaesthetic drug remimazolam and an opioid remifentanil Remimazolam is a new anaesthetic drug with a sedative effect which in combination with an opioid can be used to achieve general anaesthesia To date however no clinical trials have been conducted to specifically assess the potential for drug-drug interactions between remimazolam and remifentanil Greater understanding of the potential for such interactions will help define more appropriate dosing regimens with less over-sedation and associated side effects
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2020-003806-30 EUDRACT_NUMBER None None