Evaluation of pharmacokinetic interactions between the antidiabetic metformin andthe antibiotic trimethoprim. - MeTri

niversität Heidelberg, Medizinische Fakultät0 sites24 target enrollmentJuly 13, 2010

ConditionsE11.90

Overview

No summary available.

Registry

who.int

Start Date

July 13, 2010

End Date

March 10, 2011

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversität Heidelberg, Medizinische Fakultät

•Good state of health
•\- Voluntarily signed informed consent
•\- No clinically relevant findings in any of the investigations of the pre\-study examination, especially estimated creatinine clearance \> 60 ml/min (Cockcroft \& Gault equation)
•\- Known genotype for MATE1 and OCT2 polymorphisms from a previous study
•\- Agreement to abstain from alcoholic beverages during the time of the study.
•\- Females must agree to a reliable contraception (Pearl Index \<1%), e.g. double barrier method.

•\- Any regular drug treatment within the last two months with the exception of oral contraceptives in female volunteers and L\-thyroxine.
•\- Any intake of a substance known to inhibit drug metabolising enzymes or drug transporters within a period of less than 10 times the respective elimination half\-life.
•\- Any intake of a substance known to induce drug metabolising enzymes or drug transporters within the last two weeks (e.g. St. John’s Wort).
•\- Any acute or chronic illness or clinically relevant findings in the pre\-study examination.
•\- Creatinine clearance \< 60 ml/min as estimated with the Cockcroft \& Gault equation.
•\- Diabetes mellitus (any type).
•\- Contraindication against metformin or trimethoprim and any known intolerance to one of the substances or their composites.
•\- History of multiple and recurring allergies or allergy to the study drugs or to one of its constituents.
•\- Regular smoking.
•\- Alcohol abuse (more than approximately 20 g alcohol per day).