Bioequivalence of Two Different Generations of Drug Product of 150 mg Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double-blind, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)

简要总结

主要结局

次要结局

• Cmax (maximum measured concentration of free dabigatran in plasma)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• AUC0-infinity (area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 with t1 = 0 and t2 = 24, 48, 72 hours)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• tmax (time from dosing to the maximum concentration of the analyte in plasma)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• λz (terminal rate constant in plasma)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• t1/2 (terminal half-life of the analyte in plasma)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• MRTpo (mean residence time of the analyte in the body after oral administration)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)
• Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration)