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Completed Phase 1 Interventional Accepts healthy volunteers

Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.

ClinicalTrials.gov ID: NCT00481182

Public ClinicalTrials.gov record NCT00481182. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 3:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00481182
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2005
Primary completion
Not listed
Completion
Not listed
Last update posted
Feb 22, 2009

Started 2005

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
GSK Investigational Site Baltimore Maryland 21287-5554
GSK Investigational Site Buffalo New York 14215-1199

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00481182, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 22, 2009 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00481182 live on ClinicalTrials.gov.

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