Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

Completed · Phase 1/Phase 2

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01143051

Run by

Amphastar Pharmaceuticals, Inc.

People needed

24

Starts

2010-01-01

Expected to finish

2010-06-01

Last updated by the study team

2018-09-25

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Amphastar Location 1 — Cypress, California, United States

Full record on ClinicalTrials.gov

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