The primary objective of this study is to compare the pharmacokinetic (PK) profiles of Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg albuterol base from each product.
This is a single center, open-label, 2-period crossover study. The study consists of a screening visit followed by a treatment period comprising 2 treatment visits. The treatment period visits will be separated by a 4 to 14-day washout period. Eligible patients will be kept overnight prior to each treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Albuterol Spiromax® 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose
ProAir® HFA 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose
Teva Investigational Site 10538
Costa Mesa, California, United States
Area under the plasma albuterol concentration-time curve
Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.
Time frame: Time 0 to the last detectable plasma albuterol concentration measured up to 10 hours post-dose (AUC0-t)
Maximum observed plasma albuterol concentration (Cmax)
Blood samples for plasma albuterol concentration determination will be drawn 5 (±2) minutes prior to dosing and at 30 (±2), 60 (±5), 120 (±10), 360 (±10), and 600 (±10) minutes after the completion of dosing.
Time frame: From baseline to up to 10 hours post dose
Pharmacodynamic Effect on Vital Signs
Effects on vital signs (blood pressure, pulse rate) over 6 hours post-dosing
Time frame: From baseline to up to 6 hours post dose
Summary of participants with adverse events
Time frame: From Day 1 to end of Follow-up Visit (approximately 4 weeks)
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