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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intramuscular injection
Intramuscular injection
Intramuscular injection
FARMOVS Pty Ltd
Bloemfontein, South Africa
Area under the plasma concentration versus time curve, time zero to time of the last quantifiable concentration (AUC0-t)
Time frame: up to 36hours
Area under the plasma concentration versus time curve, with extrapolation to infinity (AUC0-∞)
Time frame: up to 36hours
Maximum observed plasma concentration Cmax
Time frame: up to 36hours
Time to peak drug concentration (Tmax) of midazolam
Time frame: up to 36 hours
Terminal half-life (T1/2) of midazolam
Time frame: up to 36 hours
Time to peak drug concentration (Tmax) of 1'OH-midazolam
Time frame: up to 36 hours
Terminal half-life (T1/2) of 1'OH-midazolam
Time frame: up to 36 hours
Maximum observed plasma concentration (Cmax) 1'OH-midazolam
Time frame: up to 36 hours
Area under the plasma concentration versus time curve from time 0 to the last measurable concentration (AUC0-t) of 1'OH-midazolam
Time frame: up to 36 hours
Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0- ∞) of 1'OH-midazolam
Time frame: up to 36 hours
Pain evaluation using the visual analogue scale (0:no pain-10:pain as bad as it could possibly be)
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Intramuscular injection
Time frame: up to 5 hours
Number of Safety/adverse events
Time frame: 7 days