A Phase 1 interventional study of Part 1 and Part 2 Group 1 in Anaphylaxis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in Germany. Open to participants aged 18 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by Bausch & Lomb Incorporated · Phase 1, Interventional, and Treatment
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
Exclusion Criteria:
History or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, gastrointestinal or pulmonary diseases especially asthma bronchiale. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study.
History or presence of silent infections, including positive tests for HIV1, HIV2, Hepatitis B or C.
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.
Device: Part 1
300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Device: Part 2 Group 1
500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Drug: Part 2 group 2
300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
Device: Part 2 group 3
300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
Device: Part 2 Group 4
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
Also known as: Group 1
300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Also known as: Group 1
500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
Also known as: Group 2
300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
Also known as: Group 3
300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
Also known as: Group 4
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 study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated