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

NCT03282929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-06-21

No results posted yet for this study

Summary

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

Conditions

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)

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Beate Klaus, MD · Baush and Lomb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2018-09-28
Completion
2018-10-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282929 on ClinicalTrials.gov