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 molecule with immunostimulating activity in animals and in men. According to a cross-over randomized study design, 12 healthy volunteers received pidotimod 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 bioavailability of the drug, probably due to an interference at the absorption level. After eating, the time of maximum plasma level was significantly longer than that observed after fasting, while AUC values and the maximum concentration were reduced by 50%. On the contrary, the pharmacokinetics after absorption phase were not influenced by food: as a matter of fact, half-life and MRT did not differ significantly when the drug was taken after fasting or after a standard meal. Finally, the two formulations used in this study resulted bioequivalent.
Department of Internal Medicine, University of Pavia, Italy.
L
L
D'Angelo
F
F
De Ponti
F
F
Crema
M
M
Caravaggi
A
A
Crema
D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D018565:Food-Drug Interactions; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D011761:Pyrrolidonecarboxylic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency; D013844:Thiazoles / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D053778:Thiazolidines
D007155:Immunologic Factors; D013844:Thiazoles; D053778:Thiazolidines; C064893:pidotimod; D011761:Pyrrolidonecarboxylic Acid