1.Antihistaminic effects of rupatadine and PKPD modelling
JUANA PENAl, MARCEL•LI CARBO. EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS 2008, Vol. 33, No.2, pp. 107-116
Data on rupatadine and desloratadine plasma con-centrations from two different clinical trials were combined in order to perform the pharmacokinetic modelling. In previous studies assessing the antihistaminic activity of rupatadine, doses of 10, 20, 40 and 80 mg rupatadine fumarate were administered, although the concentrations of the drug and its metabolite were only determined in plasma samples at the two highest doses. Other data were taken from a later bioequivalence study between solution and tablet form, where 10 mg rupatadine was administered (data not published). Concentration data from 30 healthy volunteers (18 males and 12 females, age range 18 to 44 years) coming from the two clinical trials mentioned above were used for the development of the population pharmacokinetic model.