Effect of tenidap sodium on the pharmacodynamics and plasma protein binding of warfarin in healthy volunteers.

1. An open-label, randomised study was performed to assess the effect of tenidap sodium on the pharmacodynamics and plasma protein binding of warfarin. 2. Fourteen healthy male volunteers received either a single oral dose of 120 mg tenidap sodium or matching placebo capsules from days 11 to 36. A single oral dose of 0.75 mg kg-1 warfarin was administered on days 1 and 32. 3. The mean prothrombin AUC(1,120h) value between baseline and day 32 increased from 1692.4 +/- 234.5 s h to 1769.3 +/- 218.0 s h in the group given tenidap, and decreased from 1747.6 +/- 289.4 s h to 1708.1 +/- 236.8 s h in the placebo group. 4. Tenidap caused a slight delay in the normalisation of prothrombin times following the second dose of warfarin on day 32 compared with the first dose on day 1. This was significant at 36, 48, 72 and 96 h but not at 120 h after administration of warfarin. 5. The mean percentage of unbound warfarin in the tenidap group (0.08% +/- 0.09) was significantly different (P = 0.047) from that in the placebo group (-0.03% +/- 0.10) but this was not considered to be clinically meaningful. 6. These data indicate that prothrombin times should be monitored during concomitant administration of tenidap and warfarin.

RCT Entities:   Population Interventions Outcomes