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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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 evaluated, under augmented dose conditions.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amphastar Pharmaceuticals, Inc.
• Treatments: Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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