CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
A006 DPI +3 moredrug
Likely dose
A006 DPI 110 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/NCT02271334
NCT02271334Phase 2Completed
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Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers (A Randomized, Double- or Evaluator-blinded, Single-dose, Four-arm, Crossover Pharmacokinetics (PK) Study in Healthy Adults)

Amphastar Pharmaceuticals, Inc.·interventional·Posted Oct 22, 2014·Updated Apr 19, 2017

In Brief

A Phase 2 clinical trial evaluating A006 DPI and Proventil® MDI for Asthma. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 22, 2014
Enrollment StartAug 1, 2014
Primary CompletionOct 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.7 years ago

Interventions

A006 DPIdrug

Single dose 110 mcg, 1 inhalation

A006 DPIdrug

Single dose 220 mcg, 1 inhalation

Proventil® MDIdrug

Single dose 90 mcg, 1 inhalation

Proventil® MDIdrug

Single dose 90 mcg, 2 inhalations