Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444509
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2007-03-06
Brief Title:
Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double-blind Placebo-controlled Crossover Study to Investigate the Safety Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients
Status:
COMPLETED
Status Verified Date:
2017-08
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:
This is a single centre randomised double blind two-way crossover study to investigate the safety tolerability pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X 800g containing magnesium stearate Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations Male and female patients with mildmoderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X 800g with and without magnesium stearate There will be a wash-out period of at least 5 days between doses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None