CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Arm T1: Primatene Mist HFA +2 moredrug
Likely dose
Arm T1: Primatene Mist HFA 90 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01255709
NCT01255709Phase 2Completed
CompareCT.gov

CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers

Amphastar Pharmaceuticals, Inc.·interventional·Posted Dec 7, 2010·Updated Mar 17, 2016

In Brief

A Phase 2 clinical trial evaluating Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA, and 1 other intervention for Asthma. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 7, 2010
Enrollment StartDec 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.6 years ago

Interventions

Arm T1: Primatene Mist HFAdrug

epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes

Arm T2: Primatene Mist HFAdrug

epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes

Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)drug

epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes