A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block

A pivotal, single-dose, randomized, open-label, partial replicate, three-period, three-sequence, two-treatment, three-way crossover, comparative bioavailability study. Ninety-nine, male and female volunteers, 20-45 years of age, with a body mass index (BMI) within 18.5-30.0 kg/m2, inclusive, will be enrolled. (The body weight should be over 50 kg, inclusive, respectively) A single dose of 8 puffs (eq. to budesonide 1280 μg /formoterol fumarate dihydrate 36 μg) in each study period.