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Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

NCT01255709 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

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 HFA134a propelled Metered Dose Inhaler (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.

Conditions

Interventions

DRUG

Arm T1: Primatene Mist HFA

epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes

DRUG

Arm T2: Primatene Mist HFA

epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes

DRUG

Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)

epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes

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
2010-12-31
Primary Completion
2011-01-31
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 NCT01255709 on ClinicalTrials.gov