NCT04670471

Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Paion UK Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This trial is designed to quantify the pharmacodynamic (PD) and pharmacokinetic (PK) interaction(s) 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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Remimazolam	Remimazolam is an intravenous anaesthetic and sedative drug. Remimazolam exhibits its anaesthetic effects via the benzodiazepine binding site at the GABAA receptor.
DRUG	Remifentanil	Remifentanil is a commonly used opioid in anaesthetic practice. It is a potent and fast-acting analgesic.

Timeline

• Start date: 2021-04-13
• Primary completion: 2022-01-28
• Completion: 2022-01-28
• First posted: 2020-12-17
• Last updated: 2023-09-11

Locations

1 site across 1 country: Netherlands