Study identifier:PT003010-00
ClinicalTrials.gov identifier:NCT02196714
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects
COPD
Phase 1
Yes
Glycopyrronium and Formoterol Fumarate (GFF) Dose 1, Glycopyrronium and Formoterol Fumarate (GFF) Dose 2, Glycopyrronium (GP) Dose 1, Glycopyrronium (GP) Dose 2
All
24
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2019 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
Location
Location
Baltimore, MD, United States, 21201
Arms | Assigned Interventions |
---|---|
Experimental: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID) | Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID) |
Experimental: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID) | Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID) |
Experimental: Glycopyrronium (GP) Dose 1 Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID) | Drug: Glycopyrronium (GP) Dose 1 Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID) |
Experimental: Glycopyrronium (GP) Dose 2 Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID) | Drug: Glycopyrronium (GP) Dose 2 Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID) |
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