Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02165033
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple-dose Pharmacokinetics Study of "SYN006 HFA MDI" Administered Orally to Healthy Volunteers
Sponsor:
Intech Biopharm Ltd.
Organization:
Study Overview
Official Title:
Multiple-dose Pharmacokinetics and Tolerability of "SYN006 HFA MDI" (Budesonide 180ug + Procaterol Hydrochloride 10ug/Dose HFA MDI) Administered Orally to Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: