E11
Conditions
Interventions
Group 1: Period 1: Metformin, 850 mg p.o., once daily for 2 days
Glucose syrup, 75 g glucose p.o., once daily for 2 days
Period 2: Metformin, 850 mg p.o., once daily for 2 days
Glucose syrup, 75 g glucose p.o., once daily for 2 days
trimethoprim, 200 mg p.o., twice daily for 5 days
Duration of wash-out period: at least 7, maximal 56 days
Group 2: Period 1: Metformin, 850 mg p.o., once daily for 2 days
trimethoprim, 200 mg p.o., twice daily for 5 days
Period 2: Metformin, 850 mg p.o., once daily for 2 days
Glucose syrup, 75 g glucose p.o., once daily for 2 days
Duration of wash-out period: at least 7, maximal 56 days
Sponsors
Friedrich-Alexander-Universität Erlangen-Nürnberg
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Healthy male or female - No clinically relevant findings at screening - body mass index between 18 and 30 kg/m² - willing to use contraceptive measures
Exclusion criteria
Exclusion criteria: - Clinically relevant deviation of laboratory parameters at screening - Pathologic deviations in the hemogram at screening - Fasted plasma glucose of 100 mg/dl or higher at screening - Anamnestically known glucose malabsorption - Simultaneous participation in another clinical study according to the German Drug Law - Use of other medication within 14 days before study start (except for hormonal contraceptives) - smoking of 5 or more cigarettes per day - Dependency of alcohol, illegal drugs or medication - Current, relevant disease or relevant physiologic change - Blood loss of 200 ml blood or more within 4 weeks before study start - Contraindication for the use of one of the investigational drugs - Pregnancy or lactation - No capacity to consent - dependence on one of the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary pharmacokinetic outcome: The area under the metformin plasma concentration time curve, analysed by LC/MS/MS. Time points of measurements: pre-dose until 24 hours after the second intake of metformin in each period. Primary pharmacodynamic outcome: The area under the plasma glucose concentration time curve in the oral glucose tolerance test. Time points of measurements: pre-dose until 5 hours after intake of glucose syrup. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Other kinetic and dynamic parameters of metformin and trimethoprim in blood and urine (e.g., the area under the concentration time curve for other time intervals, the maximal concentrations, the fraction excreted in the urine, the renal, extrarenal and secretory clearance, the time of maximal concentration) - The effect of genetic variants on metformin and trimethoprim concentrations and on endogenous substances in blood and urine, e.g., lactate - Gender aspects of the analyses | — |
Countries
Germany
Contacts
Public ContactFabian Müller
Institut für Experimentelle und Klinische Pharmakologie und Toxikologie, Friedrich-Alexander-Universität Erlangen-Nürnberg
Outcome results
None listed