NCT02165046

Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.

Randomized, Single-dose, Three-way Crossover Study to Assess the Bioavailability of Using SYN006 HFA MDI (Budesonide/Procaterol 180/10mcg) vs Pulmicort pMDI (Budesonide 200 μg) and Meptin Air (Procaterol 10mcg)" in Healthy Volunteer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Intech Biopharm Ltd. · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is used as a bronchodilator in the management of reversible airways obstructive pulmonary disease. Budesonide and Procaterol therefore have complementary effects, treating two different components of asthma.

Detailed description

Test drug : SYN006 HFA MDI (Budesonide + Procaterol Hydrochloride) Strength: (Budesonide 180ug and Procaterol Hydrochloride 10ug/puff) Mode of administration: Orally inhaled administration, single dose (4 puffs) Reference drug 1 : Pulmicort pMDI (Budesonide) Strength: (Budesonide 200ug/puff) Mode of administration: Orally inhaled administration, single dose (4 puffs) Reference drug 2 : Meptin Air 10ug (Procaterol Hydrochloride) Strength: (Procaterol Hydrochloride 10ug/puff) Mode of administration: Orally inhaled administration, single dose (4 puffs) One dose for each drug (Test, Reference 1 and Reference 2)with an at least 6-day washout period.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Budesonide
DRUG	Procaterol

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-04-01
• Completion: 2012-08-01
• First posted: 2014-06-17
• Last updated: 2015-06-03

Locations

1 site across 1 country: Taiwan