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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: Completed Phase 1 study, sponsored by Amphastar Pharmaceuticals.
NCT01188577 is a Phase 1 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.
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 |
What the finished NCT01188577 record still lists
NCT01188577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Epinephrine Inhalation Aerosol, HFA is the first listed.
NCT01188577 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01188577's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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