Bioavailability Study of Midazolam Administered as a Solution by Conventional Syringe or ZENEO®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL); ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh; ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area; ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh
Intervention type(s): Drug; Combination Product; Combination Product; Combination Product
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment