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Pharmacokinetic Study Of EPZICOM Tablet

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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 Investigational Site, Nagano 384-0301, Japan

GSK Investigational Site, Osaka 540-0006, Japan

GSK Investigational Site, Shizuoka 432-8002, Japan

GSK Investigational Site, Tokyo 162-0052, Japan

Additional Information

Starting date: July 2006
Last updated: October 15, 2008

Page last updated: August 20, 2015

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