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

Phase 4

Completed

• Conditions: Metformin; Organic Cation Transporter 2; Polymorphism,Single Nucleotide
• Interventions: Drug: Metformin

• Registration Number: NCT01237522
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-08
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-28
• Last Update Posted: 2010-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy volunteers
• Written consent
• rs316019 genotyped
• Age 18-65 years old

Exclusion Criteria

• Daily medication
• Alcohol abuse
• Pregnancy
• Breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homozygote for the A270S wildetype	Metformin	-
Homo- or heterozygote for A270S minor alleles	Metformin	-

Primary Outcome Measures

Name	Time	Method
Renal clearance of metformin	24 Hours

Trial Locations

Locations (1)

Institute of Public Health, Clinical Pharmacology, University of Southern Denmark; 🇩🇰 Odense, Denmark