Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Cypress, California 90630


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.

Study summary:

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.


Inclusion Criteria: - Generally healthy, male and female adults, 18-30 yrs of age at Screening; - Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion; - Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; - Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol. - Other criteria apply. Exclusion Criteria: - A recent or significant smoking history; - Use of prohibited drugs or failure to observe the drug washout restrictions; - Having been on other investigational drug/device studies in the last 30 days prior to Screening. - Other criteria apply



Primary Contact:

Study Director
Medical Director
Amphastar Pharmaceuticals, Inc.

Backup Contact:


Location Contact:

Cypress, California 90630
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.