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

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080220286
Enrollment
Unknown
Registered
2006-08-02
Start date
2006-08-02
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

HIV infection

Interventions

investigational material(s) Generic name etc : EPZICOM Tablet INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational materia

Sponsors

GlaxoSmithKline K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Main inclusion criteria: - A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the morning 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. Main exclusion criteria: - A patient developing AIDS - A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the pharmacokinetic parameters of plasma lamivudine and abacavir—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026