This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Wake Research
Raleigh, North Carolina, United States
number of participants with local injection site changes
Time frame: 28 days
number of participants with systemic changes in physical exam
Time frame: 28 days
number of participants with vital signs changes resulting in a serious adverse event
Time frame: 28 days
number of participants with ECG changes resulting in a serious adverse event
Time frame: 28 days
number of participants with laboratory changes resulting in a serious adverse event
Time frame: 28 days
time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection
Time frame: 28 days
The elimination rate constant (ke) will be estimated
Time frame: 28 days
The AUC from time 0 to the time of the last measurable concentration (AUC0-last) and the AUC from time zero to infinite time (AUC0-∞)
Time frame: 28 days
Relative bioavailability will be obtained by analysis of Cmax
Time frame: 28 days
Relative bioavailability will be obtained by analysis of AUC0-last
Time frame: 28 days
Relative bioavailability will be obtained by analysis of AUC0-∞
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Time frame: 28 days