CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Epinephrine (0.125 mg/inhalation) +2 morecombination
Likely dose
Epinephrine (0.125 mg/inhalation)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04207840
NCT04207840Phase 4Completed
CompareCT.gov

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

Amphastar Pharmaceuticals, Inc.·interventional·Posted Dec 23, 2019·Updated Mar 30, 2021

In Brief

A Phase 4 clinical trial evaluating Epinephrine (0.125 mg/inhalation), Epinephrine Injection Auto-Injector (0.3mg/0.3mL), and 1 other intervention for Pharmacokinetics and 4 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics, Epinephrine, Albuterol, Asthma, Anaphylaxis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 23, 2019
Enrollment StartDec 9, 2019
Primary CompletionDec 20, 2019
Study CompletionDec 23, 2019
TodayJul 2, 2026
Enrollment to primary: 11 daysPosted 6.5 years ago

Interventions

Epinephrine (0.125 mg/inhalation)combination

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

Epinephrine Injection Auto-Injector (0.3mg/0.3mL)combination

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.

Albuterol Sulfate (0.09 mg/inhalation)combination

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