Safety and Pharmacokinetics of Halix(TM) Albuterol Unit Dose Disposable Inhaler Versus Albuterol MDI

ClinicalTrials.gov ID: NCT03373409

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Official title

An Open-label, Single-Center, Single-Dose, 3-Way Crossover Study of the Safety and Pharmacokinetics of Albuterol Administered by the Halix(TM) Albuterol Unit Dose Disposable Inhaler

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Healthy male and female volunteers without asthma will be recruited to enroll in a single dose 3-way crossover study of the safety and pharmacokinetics of albuterol when administered using the Halix (TM) albuterol unit dose disposable dry powder inhaler (DPI) and the albuterol HFA (hydrofluoroalkane) MDI inhaler.

Study identification

NCT ID: NCT03373409
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Concentrx Pharmaceuticals, Inc.; Industry
Enrollment: 12 participants

Conditions and interventions

Conditions

Asthma

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 30, 2017 (Actual)
Primary completion: May 28, 2018 (Actual)
Completion: Jul 25, 2018 (Actual)
Last update posted: Jan 30, 2019

2017 – 2018

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
North Carolina Clinical Research	Raleigh	North Carolina	27607	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03373409, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 30, 2019 · Synced Nov 14, 2026