Expired Study
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Cypress, California 90630


Purpose:

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.


Criteria:

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


NCT ID:

NCT01143051


Primary Contact:

Study Director
Medical Director
Amphastar Pharmaceuticals, Inc.


Backup Contact:

N/A


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

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