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

PHASE4CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 9, 2019

Primary Completion Date

December 20, 2019

Study Completion Date

December 23, 2019

Conditions
PharmacokineticsEpinephrineAlbuterolAsthmaAnaphylaxis
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.

Trial Locations (1)

90630

Amphastar Study Site 0035, Cypress

All Listed Sponsors
lead

Amphastar Pharmaceuticals, Inc.

INDUSTRY

NCT04207840 - 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 | Biotech Hunter | Biotech Hunter