Status:
COMPLETED
Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Conditions:
Asthma
Bronchospasm
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (HFA-134a) as the propellant. In order to differentiate the inhaled epinephrine from the fluctuating back...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01188577
Start Date
August 1 2010
End Date
January 1 2011
Last Update
July 25 2017
Active Locations (1)
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1
Amphastar Site 0035
Cypress, California, United States, 90630