Status:

COMPLETED

Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets

Lead Sponsor:

GlaxoSmithKline

Conditions:

Virus Diseases

Eligibility:

All Genders

20+ years

Phase:

PHASE4

Brief Summary

Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted to ACV and L-valine after oral administration. In subjects with normal renal function, ACV is predominantly ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Japanese subjects with chronic renal failure undergoing hemodialysis regularly three times a week for at least 12 weeks prior to the start of the study.
  • Exclusion criteria:
  • Subjects with current alcohol dependence.
  • Subjects with gastrointestinal dysfunction that may affect drug absorption.
  • Subjects who have received an organ transplant (However, subjects with a corneal transplant or any other organ transplant that may not affect the objectives of the study will be eligible for inclusion in this study).

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    August 1 2005

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00343278

    Start Date

    July 1 2005

    End Date

    August 1 2005

    Last Update

    April 14 2015

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