Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers)

NCT01737892 Phase 1/Phase 2 TERMINATED

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 to complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK. Safety of E004 will also be evaluated.

Details

Lead sponsor	Amphastar Pharmaceuticals, Inc.
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	21
Start date	2012-11
Completion	2012-11

Conditions

• Asthma

Interventions

• Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation
• Arm C-Epinephrine Inhalation Aerosol CFC

Primary outcomes

• Calculation and Comparison of relative Bioavailability of Epinephrine — up to 30 min predose and at 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 minutes postdose
  Blood PK samples will be collected at each visit for both study arms, then the Area Under the Curve (s) will be calculated for both arms and compared to give relative bioavailability

Countries

United States