Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects
- Registration Number
- NCT02109679
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI 187004 and metformin given alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A BI 187004 multiple doses BI 187004 Treatment B BI 187004 multiple doses BI 187004 + multiple doses metformin Treatment B metformin multiple doses BI 187004 + multiple doses metformin Treatment C metformin multiple doses metformin
- Primary Outcome Measures
Name Time Method Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for metformin up to 12 hours postdose AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for metformin up to 12 hours postdose AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004 up to 24 hours postdose Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004 up to 24 hours postdose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
1307.7.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany