Status:
COMPLETED
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a stable isotope deuterium-lab...
Detailed Description
The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a m...
Eligibility Criteria
Inclusion
- Generally healthy at screening;
- Body weight ≥ 50 kg for men and ≥ 45 kg for women;
- Sitting blood pressure ≤ 135/90 mmHg;
- Demonstrating negative hIV, HBsAG and DCV-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 prior to Screening;
- 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 drug/device studies, or donated blood, in the last 30 days prior to Screening;
- Other criteria apply
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01255709
Start Date
December 1 2010
End Date
January 1 2011
Last Update
March 17 2016
Active Locations (1)
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1
Amphastar Study Site 1
Cypress, California, United States, 90630