Status:
COMPLETED
Pharmacokinetic Study Of EPZICOM Tablet
Lead Sponsor:
GlaxoSmithKline
Conditions:
HIV Infection
Eligibility:
All Genders
20-64 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00337922
Start Date
July 1 2006
Last Update
October 16 2008
Active Locations (4)
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1
GSK Investigational Site
Nagano, Japan, 384-0301
2
GSK Investigational Site
Osaka, Japan, 540-0006
3
GSK Investigational Site
Shizuoka, Japan, 432-8002
4
GSK Investigational Site
Tokyo, Japan, 162-0052