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

Study of Drug Exposure in Systemic Circulation of Primatene Mist (0.25mg) by Oral Inhalation, Versus Epinephrine Injection (0.30mg) by Intramuscular Injection and ProAir (0.18mg) by Oral Inhalation in Healthy Individuals: A Randomized, Safety Evaluator-blind, Three-Treatment, Crossover, Fasting Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pharmacokinetics
• Epinephrine
• Albuterol
• Asthma
• Anaphylaxis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-09
• Primary completion: 2019-12-20
• Completion: 2019-12-23
• First posted: 2019-12-23
• Last updated: 2021-03-30
• Results posted: 2021-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study