NCT01143051

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

Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics

• Status: Completed
• Phase: Phase 1 / 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 HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

Detailed description

This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C). * At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI. The following three randomized treatments will be self-administered, at three Study Visits: * Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation), totaling 1.25 mg of epinephrine; * Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine; * Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent). * PK blood samples will be taken from a vein at scheduled time points. * Safety parameters and adverse drug events, if any, will be monitored and documented at each study visit. An End-of-Study (EOS) safety evaluation will be conducted.

Conditions

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-06-14
• Last updated: 2018-09-25
• Results posted: 2014-07-15

Locations

1 site across 1 country: United States