Study identifier:PT010010
ClinicalTrials.gov identifier:NCT03075267
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days
Chronic Obstructive Pulmonary Disease
Phase 1
Yes
PT010 (BGF MDI) 320/14.4/9.6 µg, PT010 (BGF MDI) 160/14.4/9.6 µg, PT003 (GFF MDI) 14.4/9.6 µg
All
96
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2020 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: PT010 (BGF MDI) 320/14.4/9.6 µg PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg | Drug: PT010 (BGF MDI) 320/14.4/9.6 µg A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. Other Name: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler |
Experimental: PT010 (BGF MDI) 160/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg | Drug: PT010 (BGF MDI) 160/14.4/9.6 µg A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. Other Name: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler |
Experimental: PT003 (GFF MDI) 14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg | Drug: PT003 (GFF MDI) 14.4/9.6 µg A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. Other Name: Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler |