Clareo Health | 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 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
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Keep this study
Lead
Amphastar Pharmaceuticals, Inc.
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
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.
