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STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study

NCT ID: NCT01181505

Last Updated: 2010-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-06-30

Brief Summary

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This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in healthy subject in relation to the presence of HNF-4A G60D variant.

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Detailed Description

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After a single oral administration of 2 mg tolterodine in 31 healthy subjects (6 with the heterozygous mutation of HNF-4A G60D vs 25 subjects with wild type of that whose CYP2D6 genotype and gender were matched with variant group), blood were collected for 24hrs. Assay of tolterodine and the metabolite, 5-hyroxymethyl tolterodine was conducted using LC/MS/MS.

Conditions

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Genotype Guided(HNF4a) Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tolterodine

Group Type EXPERIMENTAL

Tolterodine

Intervention Type DRUG

Interventions

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Tolterodine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subject whose HNF4a and CYP2D6 genotype ware determined

Exclusion Criteria

* Subject whose HNF4a and CYP2D6 genotype ware not determined
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Inje University College of Medicine

Principal Investigators

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Jae-Gook Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Other Identifiers

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06-78

Identifier Type: -

Identifier Source: org_study_id

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