Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

• Status: Completed
• Trial end date: 2011-01-01
• 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), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. 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 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 Criteria:

• 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