NCT02165033

Multiple-dose Pharmacokinetics Study of "SYN006 HFA MDI" Administered Orally to Healthy Volunteers

Multiple-dose Pharmacokinetics and Tolerability of "SYN006 HFA MDI" (Budesonide 180ug + Procaterol Hydrochloride 10ug/Dose HFA MDI) Administered Orally to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (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 Batch No: BPP-033-088 Dosage Form: HFA Metered Dose Inhaler Active Substance: Budesonide 180ug and procaterol hydrochloride hydrate 10ug/dose Dosage regimen: Multiple dose (4 puffs: budesonide 720ug and procaterol hydrochloride hydrate 40ug); thirteen consecutive doses

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Budesonide/Procaterol 180/10 X 4 puffs	Budesonide/Procaterol 180/10mcg, 4 puffs, Repeated dose

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2014-06-17
• Last updated: 2015-06-03

Locations

1 site across 1 country: Taiwan