Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers
- Registration Number
- NCT02171507
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the relative bioavailability of dabigatran with and without concomitant administration of diclofenac and the relative bioavailability of diclofenac with and without concomitant administration of dabigatran etexilate
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dabigatran etexilate Dabigatran etexilate - Diclofenac Diclofenac - Dabigatran etexilate + diclofenac Dabigatran etexilate - Dabigatran etexilate + diclofenac Diclofenac -
- Primary Outcome Measures
Name Time Method Cmax (maximal concentration of diclofenac in plasma) from pre-dose up to 72 hours post-dose AUC0-infinity (area under the concentration-time curve of diclofenac in plasma extrapolated to infinity) from pre-dose up to 72 hours post-dose aPTT (activated partial thromboplastin time) and ECT (Ecarin clotting time) with and without diclofenac from pre-dose up to 72 hours post-dose ERmax,ss (maximal effect ratio of dabigatran in plasma at steady state) from pre-dose up to 72 hours post-dose AUCτ,ss on Day 4 (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval) from pre-dose up to 72 hours post-dose Cmax,ss (maximum concentration of dabigatran in plasma at steady state) from pre-dose up to 72 hours post-dose AUERτ,ss (area under the effect ratio-time curve of dabigatran in plasma at steady state over a uniform dosing interval τ) from pre-dose up to 72 hours post-dose
- Secondary Outcome Measures
Name Time Method 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