A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order
300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Nuvisan GmbH
Neu-Ulm, Wegenerstrasse 13, Germany
Cmax
Maximum observed drug concentration
Time frame: 14 days
tmax
Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)