Asthma
Conditions
Keywords
Asthma, shortness of breath, wheezing
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.
Interventions
DRUGArm T1: Primatene Mist HFA
epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
DRUGArm T2: Primatene Mist HFA
epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
DRUGArm C: Primatene Mist (epinephrine inhalation aerosol, USP)
epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
Sponsors
Amphastar Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics including maximum concentration and area under the curve | -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose. | Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3. * Mean Maximum concentration of epinephrine (Cmax for epinephrine) * Mean Area Under the Curve (AUC) for epinephrine * Time to maximum concentration (tmax) and Half life of the drug (t1/2) * Epinephrine concentrations versus time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs | within 30 min predose, at 30, 60 and 360 min postdose | Systolic and Diastolic Blood pressure and heart rate |
| 12-lead Electrocardiogram (ECG) | within 30 min pre-dose, and at 15 and 120 min post-dose | 12 lead ECG (Routine and QT/QTc intervals) |
| Telemetry ECG | within 30 min pre-dose, and during the initial 5 min post-dose | Telemetry recording of heart rate |
Countries
United States
Outcome results
None listed