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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00337922 |
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Date of registration:
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16/06/2006 |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study Of EPZICOM Tablet
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Scientific title:
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Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients - |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00337922 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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GSK Clinical Trials, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infection
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Intervention(s)
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Drug: Lamivudine / Abacavir Sulfate
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Primary Outcome(s)
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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)
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Secondary Outcome(s)
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Safety (adverse events occurring during the study period)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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