Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure
2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure
2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure
Pearl Investigative Site
Baltimore, Maryland, United States
Maximum Plasma Concentration (Cmax)-Budesonide
Maximum plasma concentration (Cmax) per Regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax)-Glycopyrronium
Maximum plasma concentration (Cmax) per Regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax)-Formoterol
Maximum plasma concentration (Cmax) per Regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax)-Budesonide
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2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax)-Formoterol
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium
Each treatment period is equal to assigned regimen
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol
Each treatment period is equal to assigned regimen
Time frame: 24 hrs