Plafibride tolerance trial in healthy volunteers.

Tolerance of N-2-(p-chlorophenoxy)-isobutyryl-N'-morpholinomethylurea (plafibride, ITA 104) administered over a 3-month period was studied in a group of healthy volunteers. Acetylsalicylic acid (ASA) was used as a reference drug. Both drugs were administered p.o. at the dose of 1600 mg/d. Plafibride showed a platelet antiaggregant effect similar in intensity to that shown by ASA, but its gastrointestinal tolerance was better. In the same way, plafibride showed a hypolipemic effect which was characterized by a decrease in the plasma level of total lipids and triglycerides and also by a drop in the percentage of the pre-beta-fraction of the lipoproteinogram at the expense of an increase in the alpha-fraction. No rebound effect was noticed when administration of the drug was stopped. The tolerance of plafibride was very good, both from the clinical and analytical point of view.