MedTrace Logo

Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults

NCT01737892 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-03-17

No results posted yet for this study

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 to complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK. Safety of E004 will also be evaluated.

Conditions

Interventions

DRUG

Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation

Epinephrine Inhalation Aerosol HFA, Single dose 125 mcg, 1 inhalation

DRUG

Arm C-Epinephrine Inhalation Aerosol CFC

Epinephrine Inhalation Aerosol - CFC, Single dose 220 mcg, 1 inhalation

Sponsors & Collaborators

  • Amphastar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Vladimir Evilevitch, M.D. · Amphastar Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT01737892 on ClinicalTrials.gov