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

niversität Heidelberg, Medizinische Fakultät0 个研究点目标入组 24 人开始时间: 2010年7月13日最近更新: 2024年8月19日

适应症

试验速览

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•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).
•- Positive drug screening or known or admitted drug abuse.
•- Known or planned pregnancy or breast feeding.
•- Blood donation or participation in a clinical trial within the last two months.

发起方

niversität Heidelberg, Medizinische Fakultät