Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456898
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2007-04-04
Brief Title:
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Randomized Open-Label 3-Period Crossover Study to Evaluate the Effect of Multiple Doses of DVS SR and Paroxetine on the CYP2D6 Biotransformation of Codeine to Morphine in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2007-12
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:
To evaluate the effects of multiple oral doses of desvenlafaxine sustained release DVS SR and paroxetine on the biotransformation of codeine to morphine in healthy subjects To assess the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to healthy subjects
Detailed Description:
This is a randomized open-label inpatientoutpatient 3-period crossover study in healthy subjectsThe study will consist of 3 treatment periods In treatment period 1 subjects will be randomly assigned on study day 1 A single 60-mg dose of codeine will be administered to all subjects In periods 2 and 3 subjects will receive either DVS SR 100 mgday or paroxetine 20 mgday until the steady state is reached At steady state subjects will receive codeine 60 mg concomitantly with either DVS SR 100 mg or paroxetine 20 mg depending on the treatment sequence to which they are assigned DVS SR 100 mg or paroxetine 20 mg administration will continue for an additional 2 days In treatment period 3 subjects will receive the alternative treatment sequence
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