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Clinical Trial Details

Trial ID: L6955
Source ID: NCT01211197
Associated Drug: C: Bi 10773 / Metformin Tablet
Title: Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01211197/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: C: BI 10773 / metformin tablet|DRUG: B: BI 10773 tablet and metformin tablet|DRUG: A: BI 10773 / metformin tablet
Outcome Measures: Primary: Empa: Area Under the Curve 0 to Infinity (AUC0-∞), Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the coefficient of variation (CV)., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Empa: Maximum Measured Concentration (Cmax), Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞), Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Metformin: Maximum Measured Concentration (Cmax), Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | Secondary: Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz), Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz), Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Time to Maximum Measured Concentration (Tmax), Time from dosing to the maximum concentration of the analyte in plasma. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Terminal Elimination Rate Constant in Plasma (λz), Terminal elimination rate constant in plasma. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Terminal Half-life in Plasma (T1/2), Terminal half-life of the analyte in plasma. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Mean Residence Time in the Body After Oral Administration (MRTpo), Mean residence time of the analyte in the body after oral administration. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Apparent Clearance After Extravascular Administration (CL/F), Apparent clearance of the analyte in the plasma after extravascular administration. Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Apparent Volume of Distribution During the Terminal Phase (Vz/F), Apparent volume of distribution during the terminal phase (λz). Note the standard deviation is actually the CV., 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator., Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events., Drug administration up to 7 days after last drug administration, up to 8 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-10
Completion Date:
Results First Posted: 2015-08-21
Last Update Posted: 2015-08-21
Locations: 1276.5.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
URL: https://clinicaltrials.gov/show/NCT01211197