Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
Completed · Phase 1/Phase 2
Conditions studied: Asthma, Bronchospasm, Wheezing, Shortness of Breath
In brief
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-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. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.
Key facts
- Study ID
- NCT01188577
- Run by
- Amphastar Pharmaceuticals, Inc.
- People needed
- 23
- Starts
- 2010-08-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2017-07-25
Who can join
Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Generally healthy at screening;
- No clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
- Body weight ≥ 50 kg for men and ≥ 45 kg for women,
- Sitting blood pressure ≤ 135/90 mm Hg;
- Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- Properly consented
- Other criteria apply
You may not qualify if…
- A smoking history of ≥10 pack-years, or having smoked within 6 months;
- Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
- Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
- Known intolerance or hypersensitivity to the study MDI ingredients;
- Having been on other investigational studies, or donated blood, in the last 30 days;
- Other Criteria Apply
Where it is running
- Amphastar Site 0035 — Cypress, California, United States
Full record on ClinicalTrials.gov
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