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NCT01143051 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
A Phase 1 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01143051: Completed Phase 1 study, sponsored by Amphastar Pharmaceuticals.
NCT01143051 is a Phase 1 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143051, a Phase 1 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT01143051 record still lists
NCT01143051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which epinephrine inhalation aerosol is the first listed.
NCT01143051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01143051 about?
NCT01143051 is a clinical study titled "Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers". This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.
What is the current status of trial NCT01143051?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01143051?
The interventions under investigation include: epinephrine inhalation aerosol (DRUG).
Who is sponsoring clinical trial NCT01143051?
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 NCT01143051's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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