Healthy Clinical Trial
Official title:
A Randomized, Single-dose, Open-label, Two-way Crossover Pivotal Study to Assess the Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) in Healthy Volunteers Under Fasting Conditions
This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA [Albuterol Sulfate] Inhalation Aerosol 90 mcg Per Actuation) in healthy volunteers under fasting conditions. The test product was considered bioequivalent to the reference product if the T/R ln-transformed AUC(0-t), AUC(0-inf), and Cmax were within 80.00-125.00% of those of the reference.
A single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover bioequivalence study was carried out under fasting conditions in healthy adults, aged 20-60 years. For each period, each subject received a single dose as equivalent to 180 mcg of albuterol of the study drugs according to the pre-determined randomization scheme. Each subject was drawn 22 times over the period of 24 hours. Plasma samples were collected and analyzed for albuterol concentrations by using LC-MS/MS. For each subject, there were 2 dosing periods separated by a 14-day washout period. During the study, standardized meals were provided to all subjects while institutionalized. ;
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