Study identifier:PT010001-00
ClinicalTrials.gov identifier:NCT01980615
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers
Healthy Volunteers
Phase 1
Yes
Inhaled BGF (PT010) Dose 1, Inhaled BGF (PT010) Dose 2, Inhaled BGF (PT010) Dose 3, Inhaled GFF (PT003), Inhaled Symbicort Dose 1, Inhaled Symbicort Dose 2
All
84
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jun 2018 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to budesonide following administration of Symbicort MDI.
Location
Location
Baltimore, MD, United States
Arms | Assigned Interventions |
---|---|
Experimental: BGF MDI (PT010) Dose 1 BGF MDI Dose 1 taken as 2 inhalations | - |
Experimental: BGF MDI (PT010) Dose 2 BGF MDI Dose 2 taken as 2 inhalations | - |
Experimental: BGF MDI (PT010) Dose 3 BGF MDI Dose 3 taken as 2 inhalations | - |
Active Comparator: GFF MDI (PT003) GFF MDI (PT003) taken as 2 inhalations | - |
Active Comparator: Symbicort MDI Dose 1 Symbicort MDI taken as 2 inhalations | - |
Active Comparator: Symbicort MDI Dose 2 Symbicort MDI Dose 2 taken as 2 inhalations | - |
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