NCT01255709

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

CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Detailed description

The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.

Conditions

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-12-07
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States