Clinical trial NCT01255709: Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
Official title: CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
shortness of breath
wheezing
Lead sponsor: Amphastar Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.

Eligibility 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

Primary outcomes:
measure: Pharmacokinetics including maximum concentration and area under the curve
timeFrame: -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose.
Secondary outcomes:
measure: Vital Signs
timeFrame: within 30 min predose, at 30, 60 and 360 min postdose
measure: 12-lead Electrocardiogram (ECG)
timeFrame: within 30 min pre-dose, and at 15 and 120 min post-dose
measure: Telemetry ECG
timeFrame: within 30 min pre-dose, and during the initial 5 min post-dose
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Amphastar Study Site 1
state: California
Study officials:
affiliation: Amphastar Pharmaceuticals, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
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