Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 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 HFA134a propelled Metered Dose Inhaler (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.

• Phase: 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;

• 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 Criteria:

• 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