NCT04113343 is a Phase 1 clinical trial of Remimazolam in Safety Issues, sponsored by Paion UK Ltd..

Who is sponsoring NCT04113343?

NCT04113343 is sponsored by Paion UK Ltd..

What drugs are being tested in NCT04113343?

Interventions in NCT04113343: Remimazolam, Alcohol.

What condition does NCT04113343 study?

NCT04113343 studies Safety Issues.

Is NCT04113343 still recruiting?

NCT04113343 is currently completed. Last updated 2 October 2019.

Last reviewed 2019-10-02 · How we verify

NCT04113343

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

Completed Phase 1 Last updated 2 October 2019

What this trial tests

Phase 1 trial testing Remimazolam in Safety Issues in 21 participants. Completed in 9 August 2017.

Timeline

30 May 2017

Primary endpoint
9 August 2017

9 August 2017

Quick facts

Lead sponsor	Paion UK Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	21
Start date	30 May 2017
Primary completion	9 August 2017
Estimated completion	9 August 2017
Sites	1 location across United States

Drugs / interventions tested

Remimazolam — full drug profile →
Alcohol — full drug profile →

Conditions studied

Safety Issues — all drugs for Safety Issues →

Sponsor

Paion UK Ltd. — full company profile →

Who can join

Adults 21 to 45, female only, with Safety Issues. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent.
Kilpatrick GJ. · · 2021 · cited 190× · PMID 34354587 · DOI 10.3389/fphar.2021.690875
Remimazolam Has Low Oral Bioavailability and No Potential for Misuse in Drug-Facilitated Sexual Assaults, with or Without Alcohol: Results from Two Randomised Clinical Trials.
Pesic M, Stöhr T, Ossig J, Borkett K, et al · · 2020 · cited 21× · PMID 32757149 · DOI 10.1007/s40268-020-00317-0

Verify or expand the search:

Other trials of Remimazolam

Trials testing the same drug.

NCT07251101 — Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery · NA · not yet recruiting
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 Safety Issues

Currently open trials in the same condition.

NCT06485141 — BeSMART Secure Storage Counseling in the Inpatient Setting · NA · recruiting
NCT06494527 — A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults · Phase 1 · active not recruiting
NCT06189170 — Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients · EARLY_PHASE1 · recruiting
NCT06509490 — NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors · NA · recruiting
NCT06498167 — Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib) · recruiting

Other Paion UK Ltd. trials

Trials by the same sponsor.

NCT04670471 — Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil · Phase 1 · completed
NCT03661489 — Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery · Phase 3 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04113343 (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: 2 October 2019

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/NCT04113343.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing