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

NCT03373409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-01-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Albuterol DPI 90mcg

Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol 90mcg will be given on one of the 3 treatment days. One inhalation from the DPI will be used.

DRUG

Albuterol DPI 180mcg

Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol 180mcg will be given on one of the 3 treatment days. Two inhalations from the DPI will be used to deliver the 180mcg dose

DRUG

Albuterol HFA MDI

Albuterol HFA MDI delivers 90mcg of albuterol with each inhalation. Albuterol 180mcg will be given on one of the 3 treatment days. Two inhalations from the MDI will be used to deliver the 180mcg dose

Sponsors & Collaborators

  • PharPoint Research, Inc.

    collaborator INDUSTRY

  • Kramer Consulting, LLC

    collaborator OTHER

  • Concentrx Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • William J Alexander, MD · Concentrx Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2018-05-28
Completion
2018-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373409 on ClinicalTrials.gov