Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481182
Status:
COMPLETED
Last Update Posted:
2009-02-23
First Post:
2007-05-30
Brief Title:
Co-Administration Of Fosamprenavir With Methadone A Drug Interaction Study
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I Open-Label 2-Period Single-Sequence Drug Interaction Study to Assess Steady-State Plasma Methadone Enantiomer Pharmacokinetics Following Co-Administration of Methadone QD With Fosamprenavir 700mg BID RTV 100mg BID in Opiate-Dependent HIV Seronegative Adult Subjects
Status:
COMPLETED
Status Verified Date:
2009-02
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:
To assess the combined effects of fosamprenavir 700mg BID ritonavir 100mg BID standardized dose of methadone on plasma total and unbound methadone enantiomer pharmacokinetics PK opiate pharmacodynamic PD measures and safety The effect of methadone on plasma amprenavir PK will also be assessed by comparison to historical control data
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