NCT03282929

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

An 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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects

Detailed description

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

Conditions

• Anaphylaxis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-03-23
• Primary completion: 2018-09-28
• Completion: 2018-10-15
• First posted: 2017-09-14
• Last updated: 2019-06-21

Locations

1 site across 1 country: Germany