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.