Pharmacodynamic effects of single and repeated doses of oral sulodexide in healthy volunteers. A placebo-controlled study with an enteric-coated formulation.
Eight male and 8 female healthy volunteers, aged on average 32 +/- 6 years, underwent a randomized, crossover study, aimed at comparing the activity on some fibrinolysis and coagulation parameters of 100 and 200 mg/day of oral sulodexide, administered as enteric-coated tablets. After the single and the repeated (for 7 days) administration of the two daily dosages, the Fibrin Plates test, the Heptest, the Plasminogen Activator Inhibitor test (as to both activity and antigen level) and the activated Partial Thromboplastin Time were checked during the first 6 hours after administration. The pro-fibrinolytic and antithrombotic activity of sulodexide was confirmed to be significant with both dosage schemes and potentiated by repeated administrations. On the other hand, the absence of any influence on aPTT confirmed the lack of interference of the drug, after oral administration, on the intrinsic pathway of coagulation. No adverse reactions or events were observed.
Mauro
M
M
Brera Medical Department, Niguarda Hospital, Milan, Italy.
Palmieri
G C
GC
Palazzini
E
E
Barbanti
M
M
Calanni Rindina
F
F
Milani
M R
MR
D000284:Administration, Oral; D000328:Adult; D001777:Blood Coagulation / Q000187:drug effects*; D001779:Blood Coagulation Factors / Q000032:analysis; D001780:Blood Coagulation Tests; D004305:Dose-Response Relationship, Drug; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects*; D006025:Glycosaminoglycans / Q000494:pharmacology*; D006801:Humans; D000960:Hypolipidemic Agents / Q000494:pharmacology*; D008297:Male
D001779:Blood Coagulation Factors; D006025:Glycosaminoglycans; D000960:Hypolipidemic Agents; C007858:glucuronyl glucosamine glycan sulfate