Pharmacokinetic Study Of EPZICOM Tablet

Phase 4

Completed

• Conditions: HIV Infection

• Registration Number: NCT00337922
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-16
• Study First Submitted QC: 2006-06-16
• Study First Posted: 2006-06-20
• Study Start: 2006-07
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-15
• Last Update Posted: 2008-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Safety (adverse events occurring during the study period)

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan