Back to resultsPharmacokinetic Study Of EPZICOM Tablet
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Lamivudine / Abacavir Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring EPZICOM, Lamivudine, Abacavir, pharmacokinetics, Japanese
Eligibility Criteria
Inclusion criteria: A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the morning (00:00 to 12:00) at least for 2 weeks prior to administration of the study drug. A patient who agrees to abstain from alcohol from 48 hours prior to administration of the study drug until completion of blood sampling for pharmacokinetic analysis. Exclusion criteria: A patient developing AIDS (Patients who developed AIDS in the past but have no symptoms or findings that may serve as indicators at screening may be eligible for the study.) A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
The following pharmacokinetic parameters of plasma lamivudine and abacavir Maximum plasma concentration(Cmax), Time to the maximum plasma concentration(tmax), Elimination half-life(t1/2), Area under the plasma concentration-time curve(AUC)
Secondary Outcome Measures
Safety (adverse events occurring during the study period)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00337922
Brief Title
Pharmacokinetic Study Of EPZICOM Tablet
Official Title
Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients -
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study was designed to explore the drug levels in the blood in Japanese HIV-infected patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total of 8 subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
EPZICOM, Lamivudine, Abacavir, pharmacokinetics, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lamivudine / Abacavir Sulfate
Primary Outcome Measure Information:
Title
The following pharmacokinetic parameters of plasma lamivudine and abacavir Maximum plasma concentration(Cmax), Time to the maximum plasma concentration(tmax), Elimination half-life(t1/2), Area under the plasma concentration-time curve(AUC)
Secondary Outcome Measure Information:
Title
Safety (adverse events occurring during the study period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the morning (00:00 to 12:00) at least for 2 weeks prior to administration of the study drug.
A patient who agrees to abstain from alcohol from 48 hours prior to administration of the study drug until completion of blood sampling for pharmacokinetic analysis.
Exclusion criteria:
A patient developing AIDS (Patients who developed AIDS in the past but have no symptoms or findings that may serve as indicators at screening may be eligible for the study.)
A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Nagano
ZIP/Postal Code
384-0301
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
432-8002
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
162-0052
Country
Japan
12. IPD Sharing Statement
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Pharmacokinetic Study Of EPZICOM Tablet
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