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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 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.

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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.

Conditions Studied

Asthma

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

FieldValue
Enrollment Target 24 participants
Start Date 2010-12
Est. Completion 2011-01
Phase Phase 2

Sponsor

Amphastar Pharmaceuticals

21 total trials

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What the Registry Record Tells You About NCT01255709

The ClinicalTrials.gov registry entry for NCT01255709 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.