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Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

NCT01143051 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-09-25

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), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

Conditions

Interventions

DRUG

epinephrine inhalation aerosol

Single dose 220 mcg/inhalation, 10 inhalations

DRUG

epinephrine inhalation aerosol

HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations

DRUG

epinephrine inhalation aerosol

HFA propelled epinephrine inhalation aerosol, 160 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
2010-01-31
Primary Completion
2010-06-30
Completion
2010-06-30

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 NCT01143051 on ClinicalTrials.gov