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NCT01737892 · ClinicalTrials.gov registry record · Phase 1
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
A Phase 1 study, sponsored by Amphastar Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01737892: Clinical Trial Phase 1 study, sponsored by Amphastar Pharmaceuticals.
NCT01737892 is a Phase 1 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01737892, a Phase 1 study, was terminated before completion, sponsored by Amphastar Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 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 to complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK. Safety of E004 will also be evaluated.
Primary Outcome
Blood PK samples will be collected at each visit for both study arms, then the Area Under the Curve (s) will be calculated for both arms and compared to give relative bioavailability
Interventions
- DRUG Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation
- DRUG Arm C-Epinephrine Inhalation Aerosol CFC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2012-11 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
Why NCT01737892 stopped before completion
NCT01737892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation is the first listed.
NCT01737892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01737892 about?
NCT01737892 is a clinical study titled "Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults". 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 NCT01737892?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2012-11. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01737892?
The interventions under investigation include: Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation (DRUG), Arm C-Epinephrine Inhalation Aerosol CFC (DRUG).
Who is sponsoring clinical trial NCT01737892?
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 NCT01737892's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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