Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500201
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2007-07-10
Brief Title:
A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single Blind Double Dummy Placebo Controlled Randomized 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers
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:
Study to compare PK of a new 120mg tablet with two 60mg tablets This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients The study is planned to consist of a single part with two dosing periods periods 1 and 2 consisting of 18 subjects There will be 20 days washout between each dose Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo If 120mg SB-773812 is well tolerated in the first four volunteers the remaining 12 subjects will be dosed If the 120mg single oral dose in the first 4 subjects is poorly tolerated the study will be stopped Subjects will return to the centre for follow-up 14 to 21 days after the final doseIt is expected that the total duration of the study should be approximately 11 weeks
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