Study of the effect of miglitol on the pharmacokinetics and pharmacodynamics of warfarin in healthy males.
This was a double-blind, randomised, placebo-controlled, cross-over study to determine the possible pharmacodynamic and pharmacokinetic interaction of miglitol (CAS 72432-03-2, Bay m 1099) and warfarin sodium (CAS 129-06-6) in healthy volunteers. The study comprised 2 treatment periods of 8 days each, with a medication-free period of 14 days between the 2 treatment periods. The volunteers received medication for 7 days and were assessed over 8 days in both treatment periods. According to the randomisation, the volunteers received either 100 mg of miglitol or matching placebo, 3 times daily during the treatment periods. On Day 4 of each treatment period the volunteers received a single oral dose of 25 mg warfarin sodium together with miglitol or placebo. The effect of miglitol on both the pharmacokinetics and pharmacodynamics (prothrombin time and clotting factor VII activity) of warfarin sodium was investigated. The study results indicate that the concomitant administration of miglitol and warfarin does not affect the pharmacokinetics of R- and S-warfarin, or the pharmacodynamics of warfarin.
Schall
R
R
Department of Pharmacology, University of the Orange Free State, Bloemfontein, South Africa.
Müller
F O
FO
Hundt
H K
HK
Duursema
L
L
Groenewoud
G
G
Middle
M V
MV
D017485:1-Deoxynojirimycin / Q000031:analogs & derivatives; D000328:Adult; D000925:Anticoagulants / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D001777:Blood Coagulation / Q000187:drug effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004347:Drug Interactions; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000494:pharmacology*; D005944:Glucosamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D005959:Glucosidases / Q000037:antagonists & inhibitors*; D006801:Humans; D050112:Imino Pyranoses; D008297:Male; D013237:Stereoisomerism; D014859:Warfarin / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*
D000925:Anticoagulants; D004791:Enzyme Inhibitors; D050112:Imino Pyranoses; C045621:miglitol; D017485:1-Deoxynojirimycin; D014859:Warfarin; D005959:Glucosidases; D005944:Glucosamine