Plafibride tolerance trial at increasing doses in healthy volunteers.
Tolerance of N-2-(p-chlorophenoxy)-isobutyryl-N'-morpholinomethylurea (plafibride ITA 104), was studied in a group of healthy volunteers. Bis[2-(p-chlorophenoxy)-2-methylpropionato]-hydroxyaluminum (alufibrate) was used as a reference drug. Treatment with both drugs was carried out at progressively increasing doses from 50 to 1600 mg/d. Both products were administered p.o. Plafibride showed a platelet antiaggregant effect at the dose of 800 mg/d, which was more evident at the dose of 1600 mg/d. Alufibrate showed no platelet antiaggregant effect. Both drugs showed a similar type of hypolipemic effect which was a little higher in the case of alufibrate. No side effects of any kind were noticed with either of the two drugs.
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001772:Blood Cell Count; D001786:Blood Glucose / Q000378:metabolism; D002994:Clofibrate / Q000031:analogs & derivatives*; D002995:Clofibric Acid / Q000031:analogs & derivatives* / Q000633:toxicity; D004311:Double-Blind Method; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D000960:Hypolipidemic Agents / Q000633:toxicity*
D001786:Blood Glucose; D000960:Hypolipidemic Agents; C005681:alfibrate; D002995:Clofibric Acid; C016894:plafibride; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D002994:Clofibrate