Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT00369304
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2006-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Study Overview
Official Title:
A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: