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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04207840
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amphastar Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pharmacokinetics, Epinephrine, Albuterol, Asthma, Anaphylaxis
Arms & Interventions

Arms

Experimental: Primatene Mist, E004

Participants who dosed with Primatene Mist.

Active Comparator: Epinephrine Injection Auto-Injector (Generic of EpiPen)

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

Active Comparator: Albuterol HFA

Participants who dosed with Albuterol HFA.

Interventions

Combination Product: - Epinephrine (0.125 mg/inhalation)

Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg.

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

Participants will receive an intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL). The 0.30 mL dose will be given perpendicularly as a single deep intramuscular injection into the anterolateral aspect of the thigh.

Combination Product: - Albuterol Sulfate (0.09 mg/inhalation)

Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Amphastar Study Site 0035, Cypress, California

Status

Recruiting

Address

Amphastar Study Site 0035

Cypress, California, 90630

Site Contact

Amphastar Pharmaceuticals, Inc.

info@amphastar.com

909-980-9484

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