NCT02850484

A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block

A Single-Dose, Randomized, Open-Label, 2-Treatment, 3-Period, 3-Sequence, 3-Way Crossover, Partial Replicate, Oral Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Intech Biopharm Ltd. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA Inhaler and Symbicort 160/4.5μg in healthy volunteers with charcoal block.

Detailed description

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 (equivalent to budesonide 1280 μg/formoterol fumarate dihydrate 36 μg) in each study period.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Budesonide	Inhaled corticosteroid
DRUG	Formoterol	Long Acting Beta Agonist (LABA)

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-08-01
• Last updated: 2016-08-01