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

Healthy Clinical Trial

Official title:
A Single Center, Single Dose, Open Label, Randomized, Four-period Crossover Study in Healthy Subjects to Describe and Compare the Plasma Pharmacokinetics of Midazolam After Intramuscular Injection as a Solution by a Conventional Syringe or by the Needle-free Injector ZENEO®

Clinical Trial 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.

Clinical Trial Description

Secondary objectives are: - To describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the ventrogluteal area 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. - To describe the plasma pharmacokinetics of midazolam after single intramuscular injection through clothing 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. - To describe the plasma pharmacokinetics of midazolam after single intramuscular injection through clothing in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by the needle-free injector Zeneo® in terms of relative bioavailability and bioequivalence. - 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 ventrogluteal area by the needle-free injector Zeneo® in terms of relative bioavailability and bioequivalence - To assess and compare the pharmacokinetics of the major active metabolite 1'-OH midazolam after a single intramuscular injection i.m. administration when delivered by ZENEO®® orvs. administration by conventional syringe (Reference)conventional syringe with needle. - To assess and compare the pharmacokinetics of ZENEO® Midazolam (10mg / 0.625mL) administered in the thigh on bare skin and ZENEO® Midazolam (10mg / 0.625mL) administered in the thigh through clothing. - To assess safety and tolerability of midazolam after a single intramuscular injection single i.m. administration whenby delivered by ZENEO® vs. administrationor by conventional syringe (Reference) by conventional syringe with needle. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05026567
Study type Interventional
Source Crossject
Contact
Status Completed
Phase Phase 1
Start date May 9, 2022
Completion date July 15, 2022
View Details
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