Pharmacokinetic Study Of EPZICOM Tablet
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: Lamivudine / Abacavir Sulfate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients -
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: 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: Safety (adverse events occurring during the study period)
Eligibility
Minimum age: 20 Years.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
GSK clinical trials call center, Nagano 384, Japan
GSK clinical trials call center, Shizuoka 432, Japan
Additional Information
Starting date: May 2006
Last updated: November 12, 2007
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