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Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

NCT01188577 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-07-25

Study results available
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Summary

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.

Conditions

Interventions

DRUG

Epinephrine Inhalation Aerosol, HFA

10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation

DRUG

Epinephrine Inhalation Aerosol

Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations

Sponsors & Collaborators

  • Amphastar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Amphastar Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-09-30
Completion
2011-01-31

Countries

  • United States

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 NCT01188577 on ClinicalTrials.gov