NCT05026567

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

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®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Crossject · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL)	Intramuscular injection
COMBINATION_PRODUCT	ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh	Intramuscular injection
COMBINATION_PRODUCT	ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area	Intramuscular injection
COMBINATION_PRODUCT	ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh	Intramuscular injection

Timeline

• Start date: 2022-05-09
• Primary completion: 2022-07-14
• Completion: 2022-07-15
• First posted: 2021-08-30
• Last updated: 2022-07-22

Locations

1 site across 1 country: South Africa