Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 21 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01737892
The ClinicalTrials.gov registry entry for NCT01737892 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 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 Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation is the first listed.
NCT01737892 reports 0 study locations.
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
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.