Status:
COMPLETED
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Conditions:
Asthma
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), in healthy male and female adult volunteers. Safety of E004 will also be ...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01143051
Start Date
January 1 2010
End Date
June 1 2010
Last Update
September 25 2018
Active Locations (1)
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1
Amphastar Location 1
Cypress, California, United States, 90630