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NCT04670471
Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil
Phase 1 trial testing Remimazolam in Anesthesia in 28 participants. Completed in 28 January 2022.
28 January 2022
Quick facts
| Lead sponsor | Paion UK Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 28 |
| Start date | 13 April 2021 |
| Primary completion | 28 January 2022 |
| Estimated completion | 28 January 2022 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Remimazolam — full drug profile →
- Remifentanil — full drug profile →
Conditions studied
- Anesthesia — all drugs for Anesthesia →
Sponsor
Paion UK Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Influence of Remifentanil on the Pharmacokinetics and Pharmacodynamics of Remimazolam in Healthy Volunteers.
Vellinga R, Koomen JV, Eleveld DJ, Stöhr T, et al · · 2025 · cited 6× · PMID 40067039 · DOI 10.1097/aln.0000000000005348
Verify or expand the search:
- PubMed search for NCT04670471
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Remimazolam
Trials testing the same drug.
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- NCT07459322 — The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy · NA · not yet recruiting
- NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07269808 — Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration · Phase 3 · recruiting
- NCT06231563 — Ketamine for Veterans With Parkinson's Disease · Phase 2 · recruiting
Other recruiting trials for Anesthesia
Currently open trials in the same condition.
- NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07465185 — Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery · Phase 2 · recruiting
- NCT07269808 — Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration · Phase 3 · recruiting
- NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting
Other Paion UK Ltd. trials
Trials by the same sponsor.
- NCT03661489 — Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery · Phase 3 · completed
- NCT04113343 — Oral Remimazolam With and Without Alcohol in Healthy Female Subjects · Phase 1 · completed
- NCT03329014 — A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability · Phase 1 · completed
- NCT04113564 — Absolute Oral Bioavailability of Remimazolam · Phase 1 · completed
- NCT04110535 — Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04670471 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Paion UK Ltd.
- Last refreshed: 11 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04670471.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing