Relative Bioavailability of Dabigatran and Diclofenac After 150 mg b.i.d. Dabigatran Etexilate and Diclofenac at 50 mg Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple- Dose, Three-way Crossover Study)

简要总结

主要结局

次要结局

• AUC0-tz,ss (area under the concentration-time curve of dabigatran in plasma from the time point 0 after the last dose at steady state to the last quantifiable dabigatran plasma concentration within the uniform dosing interval τ)(from pre-dose up to 72 hours post-dose)
• tmax,ss (time from last dosing to the maximum concentration of dabigatran in plasma at steady state on Day 4)(from pre-dose up to 72 hours post-dose)
• CL/Fss (apparent clearance of dabigatran in the plasma at steady state after extravascular multiple dose administration)(from pre-dose up to 72 hours post-dose)
• tmin,ss (time from last dosing to the minimum concentration of dabigatran in plasma at steady state over a uniform dosing interval τ)(from pre-dose up to 72 hours post-dose)
• Cpre,ss (pre-dose concentration of dabigatran in plasma at steady state immediately before administration of the next dose)(from pre-dose up to 72 hours post-dose)
• MRTp.o.,ss (mean residence time of dabigatran in the body at steady state after oral administration)(from pre-dose up to 72 hours post-dose)
• CLR,ss (renal clearance of dabigatran at steady state determined over the dosing interval τ)(from pre-dose up to 72 hours post-dose)
• C min,ss (minimum measured concentration of dabigatran in plasma at steady state over a uniform dosing interval τ)(from pre-dose up to 72 hours post-dose)
• tz,ss (time of last measurable concentration of dabigatran in plasma within the dosing interval τ at steady state)(from pre-dose up to 72 hours post-dose)
• Vz/Fss (apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration)(from pre-dose up to 72 hours post-dose)
• Aeτ,ss (amount of dabigatran that is eliminated in urine at steady state over a uniform dosing interval τ)(0 to 12 h and 12 to 24 h after administration on day 4)
• feτ,ss (fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ)(0 to 12 h and 12 to 24 h after administration on day 4)
• AUC0-tz (area under the concentration-time curve of diclofenac and 4´- hydroxydiclofenac in plasma over the time interval 0 to the last quantifiable analyte plasma concentration after single dose administration)(from pre-dose up to 72 hours post-dose)
• tz (time of last measurable concentration of diclofenac and 4´- hydroxydiclofenac in plasma following a single dose)(from pre-dose up to 72 hours post-dose)
• %AUCtz-infinity (percentage of the AUC0-infinity that is obtained by extrapolation) for diclofenac and 4´- hydroxydiclofenac(from pre-dose up to 72 hours post-dose)
• tmax (time from dosing to the maximum concentration of diclofenac and 4´- hydroxydiclofenac in plasma following a single dose)(from pre-dose up to 72 hours post-dose)
• λz (terminal rate constant in plasma after a single dose) for diclofenac and 4´- hydroxydiclofenac(from pre-dose up to 72 hours post-dose)
• t1/2 (terminal half-life of diclofenac and 4´- hydroxydiclofenac in plasma after a single dose)(from pre-dose up to 72 hours post-dose)
• MRTp.o. (mean residence time of diclofenac and 4´- hydroxydiclofenac in the body after single dose oral administration)(from pre-dose up to 72 hours post-dose)
• CL/F (apparent clearance of diclofenac and 4´- hydroxydiclofenac in the plasma after extravascular single dose administration)(from pre-dose up to 72 hours post-dose)
• Vz/F (apparent volume of distribution during the terminal phase λz following extravascular dose) for diclofenac and 4´- hydroxydiclofenac(from pre-dose up to 72 hours post-dose)