Bioavailability Study of Midazolam Administered as a Solution by Conventional Syringe or ZENEO®

Phase 1 Completed 40 enrolled Crossject

RandomizedCrossoverOpen-labelTreatment

Summary

Primary objective of this study is to describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.

Timeline

Start: 2022-05-09
Primary completion: 2022-07-14
Completion: 2022-07-15

Publications

Lacombe O, Pletan Y, Grouin JM, Brennan A, Gire O. Relative Bioavailability Study of Midazolam Intramuscularly Administered with the Needle-Free Auto-Injector ZENEO(R) in Healthy Adults. Neurol Ther. 2024 Aug;13(4):1155-1172. doi: 10.1007/s40120-024-00627-4. Epub 2024 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Midazolam	Small molecule	10 mg	Intramuscular

Indications

No indication recorded.