NCT03282929View on ClinicalTrials.gov

Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 23, 2017

Primary Completion Date

September 28, 2018

Study Completion Date

October 15, 2018

Conditions
Anaphylaxis
Interventions
DEVICE

Part 1

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 2 Group 1

300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

DRUG

Part 2 group 2

500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)

DEVICE

Part 2 group 3

300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)

DEVICE

Part 2 Group 4

300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)

Trial Locations (1)

89231

Nuvisan GmbH, Neu-Ulm

All Listed Sponsors
lead

Bausch & Lomb Incorporated

INDUSTRY

NCT03282929 - Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD) | Biotech Hunter | Biotech Hunter