Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

Phase 1 Completed 21 enrolled Paion UK Ltd. PRA Health Sciences · collab

Non-randomizedSequentialOpen-labelOther

Summary

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

Timeline

Start: 2017-05-30
Primary completion: 2017-08-09
Completion: 2017-08-09

Publications

Pesic M, Stohr T, Ossig J, Borkett K, Donsbach M, Dao VA, Webster L, Schippers F. 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. Drugs R D. 2020 Sep;20(3):267-277. doi: 10.1007/s40268-020-00317-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Remimazolam	Small molecule	360 mg	Oral

Indications

No indication recorded.