Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Asthma; Epinephrine; Albuterol; Anaphylaxis; Pharmacokinetics

Treatments: Combination Product: Epinephrine Injection Auto-Injector (0.3mg/0.3mL); Combination Product: Albuterol Sulfate (0.09 mg/inhalation); Combination Product: Epinephrine (0.125 mg/inhalation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04207840

API-E004-CL-I

Details and patient eligibility

About

To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Agree to participate; understand and sign informed consent;
• Male and female adults, aged 18 to 50 years, inclusive at Screening;
• Generally healthy and medically stable, with no clinically significant abnormalities based on physical examination and laboratory tests as determined by the Investigators;
• Have good venous access;
• Have normal resting blood pressure and normal heart rate (HR) without history of syncope; a subject with out of range blood pressure may be enrolled in the study at the discretion of the Principal Investigator;
• Have a body mass index (BMI) of 18.0 - 30.0 kg/m^2;
• Female candidates must be >1 year post-menopausal or practicing a clinically acceptable form of birth control and confirmed by negative urine or serum pregnancy test at Screening;
• Negative HIV-Ab, HBs-Ag and HCV-Ab;
• Negative alcohol test (urine or breathalyzer);
• Negative drug screening results;
• Currently non-smoker; have not used any tobacco products for at least three (3) months prior to Screening; and
• Demonstrate proficiency in the use of MDI and a consistent inhalation time >2.0 seconds after training, for at least three (3) times, with a maximum of 5 attempts.

Exclusion criteria

• Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
• Known intolerance or hypersensitivity to any component of the study drugs (i.e., Epinephrine, Albuterol Sulfate or any sympathomimetic drugs, HFA-134a, thymol, ethanol, ascorbic acid, nitric acid, and hydrochloric acid).
• Upper or lower respiratory tract infection, or other systemic infection within 6 weeks prior to Screening;
• Clinically significant abnormalities in the screening/baseline ECG; prolonged corrected QT interval (QTcF) on ECG: men >450ms, women: >470ms; single or multiple premature ventricular contractions (PVC);
• Abnormal thyroid function test (if TSH is out of range, refer to T3/T4 for thyroid function assessment);
• Subject has been on other investigational drug/device studies within 30 days of Screening Visit or planned participation in another investigational drug trial at any time during this trial;
• Women who are pregnant or lactating or planning a pregnancy during the study period;
• Subject has donated or lost > 500 mL of blood within 3 months of Screening;
• Evidence of alcohol or drug abuse or dependency within 6 months prior to screening; or
• Use of any of the prohibited drugs without appropriate washout.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 3 patient groups

Primatene Mist, E004

Experimental group

Description:

Participants who dosed with Primatene Mist.

Treatment:

Combination Product: Epinephrine (0.125 mg/inhalation)

Epinephrine Injection Auto-Injector (Generic of EpiPen)

Active Comparator group

Description:

Participants who were dosed with an Epinephrine Injection Auto-Injector.

Treatment:

Combination Product: Epinephrine Injection Auto-Injector (0.3mg/0.3mL)

Albuterol HFA

Active Comparator group

Description:

Participants who dosed with Albuterol HFA.

Treatment:

Combination Product: Albuterol Sulfate (0.09 mg/inhalation)