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NCT01255709 · ClinicalTrials.gov registry record · Phase 2
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
A Phase 2 study of Asthma, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01255709: Completed Phase 2 study of Asthma, sponsored by Amphastar Pharmaceuticals.
NCT01255709 is a Phase 2 study of Asthma that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 24 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01255709, a Phase 2 study of Asthma, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (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.
Primary Outcome
Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3. * Mean Maximum concentration of epinephrine (Cmax for epinephrine) * Mean Area Under the Curve (AUC) for epinephrine * Time to maximum concentration (tmax) and Half life of the drug (t1/2) * Epinephrine concentrations versus time
Conditions Studied
Interventions
- DRUG Arm T1: Primatene Mist HFA
- DRUG Arm T2: Primatene Mist HFA
- DRUG Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
Study Locations (1)
California
- Amphastar Study Site 1 - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT01255709 record still lists
NCT01255709 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 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Arm T1: Primatene Mist HFA is the first listed.
NCT01255709 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01255709 about?
NCT01255709 is a clinical study titled "Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS". This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epineph...
What is the current status of trial NCT01255709?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-12. Estimated completion is 2011-01.
What conditions does trial NCT01255709 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01255709?
The interventions under investigation include: Arm T1: Primatene Mist HFA (DRUG), Arm T2: Primatene Mist HFA (DRUG), Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) (DRUG).
Who is sponsoring clinical trial NCT01255709?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01255709 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01255709's enrollment target sits among peer trials
24 326th of 374 higher than 47 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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