Overview

Pharmacokinetic Study Of EPZICOM Tablet

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Abacavir
Dideoxynucleosides
Lamivudine
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