Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-04 @ 4:09 AM
Study NCT ID:
NCT00989404
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2009-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Randomized, Placebo Controlled, 3-Way Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo 10mg Administered Twice Daily for 5 Days by a Rotahaler Compared to the Diskhaler in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-06
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:
NAI113625
Brief Summary:
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device.
Detailed Description:
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler to placebo within the Rotahaler presentation and to the Diskhaler. Eighteen subjects will receive each of three treatments for 5 days in a 3-way crossover design.
Study Oversight
Has Oversight DMC:
False
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?: