Pharmacokinetic Study Of EPZICOM Tablet

Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients -

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00337922

Enrollment

Registered

2006-06-20

Start date

2006-07-31

Completion date

Unknown

Last updated

2008-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

EPZICOM, Lamivudine, Abacavir, pharmacokinetics, Japanese

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.

Interventions

DRUGLamivudine / Abacavir Sulfate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety (adverse events occurring during the study period)	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026