A single-center, randomized, open-label cross-over study to investigate the drug-drug interaction of trimethoprim and metformin in healthy volunteers

Phase 1

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00004349
• Lead Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-28
• Study Completion: 2014-02-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 13

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>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 Outcome Measures

Name	Time	Method
- 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)<br>- The effect of genetic variants on metformin and trimethoprim concentrations and on endogenous substances in blood and urine, e.g., lactate<br>- Gender aspects of the analyses<br>