Lack of effect of pantoprazole on the pharmacodynamics and pharmacokinetics of warfarin.
Twenty-six healthy males took part in this double-blind, randomised, placebo-controlled, two-period, cross-over study. Pantoprazole (40 mg) (test) or placebo (reference) were administered once daily, for 8 days, with a 3 week washout period. A single oral dose of 25 mg warfarin sodium was co-administered with pantoprazole or placebo on Day 2 of each treatment period. The 90% confidence intervals for the 'test/reference' mean ratios of the excess AUC(0.168 h) of prothrombin time and AUC(0.168 h) of factor VII, and of Cmax, AUC and t1/2 of both R- and S-warfarin fell within the equivalence range of 80% to 125%. These results suggest that pantoprazole does not alter the pharmacokinetics or pharmacodynamics of warfarin.
Duursema
L
L
FARMOVS Institute for Clinical Pharmacology and Drug Development, Department of Pharmacology, University of the Orange Free State, Bloemfontein, Republic of South Africa.
Müller
F O
FO
Schall
R
R
Middle
M V
MV
Hundt
H K
HK
Groenewoud
G
G
Steinijans
V W
VW
Bliesath
H
H
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D001562:Benzimidazoles / Q000494:pharmacology*; D001777:Blood Coagulation / Q000187:drug effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004347:Drug Interactions; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors; D013454:Sulfoxides / Q000494:pharmacology*; D014859:Warfarin / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D054328:Proton Pump Inhibitors; D013454:Sulfoxides; D014859:Warfarin; D000077402:Pantoprazole; D009853:Omeprazole