EFFECT OF FOOD ON THE BIOAVAILABILITY OF PIDOTIMOD IN HEALTHY-VOLUNTEERS

Pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]- thiazolidine-4 -carboxylic acid, PGT/1A, CAS 121808-62-6) is a dipeptide-like molecul e with immunostimulating activity in animals and in men. According to a cross-over randomized study design, 12 healthy volunteers received p idotimod both as 800 mg sachets and 800 mg ampoules after fasting and after a standard meal. The intake of a standard meal before pidotimod administration either as sachet or as ampoule, reduced the bioavailabi lity of the drug, probably due to an interference at the absorption le vel. After eating, the time of maximum plasma level was significantly longer than that observed after fasting, while AUC values and the maxi mum concentration were reduced by 50 %. On the contrary, the pharmacok inetics after absorption phase were not influenced by food. as a matte r of fact, half-life and MRT did not differ significantly, when the dr ug was taken after fasting or after a standard meal. Finally, the two formulations used in this study resulted bioequivalent.