Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01188577 · ClinicalTrials.gov registry record · Phase 1
Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
A Phase 1 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01188577 is a Phase 1 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 23 participants.
The verdict
NCT01188577, a Phase 1 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.
Interventions
- DRUG Epinephrine Inhalation Aerosol, HFA
- DRUG Epinephrine Inhalation Aerosol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01188577
The ClinicalTrials.gov registry entry for NCT01188577 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Epinephrine Inhalation Aerosol, HFA is the first listed.
NCT01188577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01188577 about?
NCT01188577 is a clinical study titled "Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics". This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adul...
What is the current status of trial NCT01188577?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-08. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01188577?
The interventions under investigation include: Epinephrine Inhalation Aerosol, HFA (DRUG), Epinephrine Inhalation Aerosol (DRUG).
Who is sponsoring clinical trial NCT01188577?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.