Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00343278 |
Recruitment Status
:
Completed
First Posted
: June 22, 2006
Last Update Posted
: April 14, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Virus Diseases | Drug: Valaciclovir Hydrochloride | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Post-Marketing Clinical Study of Valaciclovir Hydrochloride Tablets -Single Oral Dose Study in Hemodialysis Patients- |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | August 2005 |
- - The pharmacokinetic parameters for VACV, ACV and CMMG - Relationship between ALDH2 genotypes and the pharmacokinetics of VACV, ACV and CMMG in blood
- - Change in blood ACV and CMMG concentrations after a 4-hour hemodialysis session - Safety (adverse events occurring during the study, clinical laboratory tests)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343278
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00343278 History of Changes |
Other Study ID Numbers: |
104689 |
First Posted: | June 22, 2006 Key Record Dates |
Last Update Posted: | April 14, 2015 |
Last Verified: | April 2015 |
Keywords provided by GlaxoSmithKline:
Valaciclovir Hydrochloride hemodialysis patient ALDH pharmacokinetics Japanese |
Additional relevant MeSH terms:
Virus Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents |