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

Metformin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237522
• Other study ID #: AKF- 377
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2010
• Last updated: December 28, 2010
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2010
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Written consent

• rs316019 genotyped

• Age 18-65 years old

Exclusion Criteria:

• Daily medication

• Alcohol abuse

• Pregnancy

• Breastfeeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Metformin
• Organic Cation Transporter 2
• Polymorphism,Single Nucleotide

Intervention

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

Locations

Country	Name	City	State
Denmark	Institute of Public Health, Clinical Pharmacology, University of Southern Denmark	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal clearance of metformin		24 Hours	No