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A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01237522
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
4
Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that renal clearance of metformin is affected in Caucasian with the known single nucleotide polymorphisms A270S in OCT2.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers.
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Homozygote for the A270S wildetype

Drug: Metformin
A single dose study with one tablet of metformin 500 mg, time frame 24 hours
Other Names:
  • Orabet

    		•
    Active Comparator: Homo- or heterozygote for A270S minor alleles

    Drug: Metformin
    A single dose study with one tablet of metformin 500 mg, time frame 24 hours
    Other Names:
  • Orabet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Renal clearance of metformin [24 Hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy volunteers

    • Written consent

    • rs316019 genotyped

    • Age 18-65 years old

    Exclusion Criteria:

    • Daily medication

    • Alcohol abuse

    • Pregnancy

    • Breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Public Health, Clinical Pharmacology, University of Southern Denmark Odense Denmark 5000

    Sponsors and Collaborators

    • University of Southern Denmark

    Investigators

    • Study Chair: Kim Broesen, Professor, University of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01237522
    Other Study ID Numbers:
    • AKF- 377
    First Posted:
    Nov 9, 2010
    Last Update Posted:
    Dec 29, 2010
    Last Verified:
    Jun 1, 2010
    Keywords provided by , ,
    Diabetes Mellitus, Type 2
    Metabolic Clearance Rate
    Pharmacokinetics
    Pharmacogenetics
    Additional relevant MeSH terms:
    Metformin

    Study Results

    No Results Posted as of Dec 29, 2010