drugset / Trial / NCT04670471
Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil
Phase 1
Completed
28 enrolled
Paion UK Ltd.
QPS Holdings LLC · collabUniversity Medical Center Groningen · collab
RandomizedSequentialOpen-labelBasic science
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.
Timeline
- Start
- 2021-04-13
- Primary completion
- 2022-01-28
- Completion
- 2022-01-28
Publications
- Background Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94. doi: 10.1007/BF01143186.
- Vellinga R, Koomen JV, Eleveld DJ, Stohr T, Pesic M, Struys MMRF, Colin PJ. Influence of Remifentanil on the Pharmacokinetics and Pharmacodynamics of Remimazolam in Healthy Volunteers. Anesthesiology. 2025 Apr 1;142(4):666-679. doi: 10.1097/ALN.0000000000005348. Epub 2025 Jan 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remifentanil | Small molecule | 0.1 ng/ml | — |
| Subject | Remifentanil | Small molecule | 0.5 ng/ml | — |
| Subject | Remifentanil | Small molecule | 1 ng/ml | — |
| Subject | Remifentanil | Small molecule | 2 ng/ml | — |
| Subject | Remifentanil | Small molecule | 4 ng/ml | — |
| Subject | Remimazolam | Small molecule | — | Intravenous |
Indications
No indication recorded.