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NCT04207840 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study of Asthma and Pharmacokinetics, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04207840: Completed Phase 4 study of Asthma and Pharmacokinetics, sponsored by Amphastar Pharmaceuticals.
NCT04207840 is a Phase 4 study of Asthma and Pharmacokinetics that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 28 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04207840, a Phase 4 study of Asthma and Pharmacokinetics, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. C\[max\] will be obtained directly from the plot of PK curve.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Epinephrine (0.125 mg/inhalation)
- COMBINATION_PRODUCT Epinephrine Injection Auto-Injector (0.3mg/0.3mL)
- COMBINATION_PRODUCT Albuterol Sulfate (0.09 mg/inhalation)
Study Locations (1)
California
- Amphastar Study Site 0035 - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2019-12-23 |
| Phase | Phase 4 |
What the finished NCT04207840 record still lists
NCT04207840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Epinephrine (0.125 mg/inhalation) is the first listed.
NCT04207840 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04207840 about?
NCT04207840 is a clinical study titled "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". 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.
What is the current status of trial NCT04207840?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2019-12-09. Estimated completion is 2019-12-23.
What conditions does trial NCT04207840 study?
This clinical trial studies the following conditions: Asthma, Pharmacokinetics, Anaphylaxis, Epinephrine, Albuterol.
What interventions are being tested in trial NCT04207840?
The interventions under investigation include: Epinephrine (0.125 mg/inhalation) (COMBINATION_PRODUCT), Epinephrine Injection Auto-Injector (0.3mg/0.3mL) (COMBINATION_PRODUCT), Albuterol Sulfate (0.09 mg/inhalation) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04207840?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04207840 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04207840's enrollment target sits among peer trials
28 311th of 374 higher than 60 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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