Title: Bioavailability and bioequivalence research for chewable tablet of citalopram hydrobromide in healthy volunteers.
Abstract: Objective To compare the relative bioavailability and the bioequivalence between domestic-made chewable tablets(to be tested)and imported tablets(reference)of citalopram hydrobromide and evaluate the bioequivalence of the two preparations.Methods A single dose of 20 mg of chewable tablets or referenced tablet of citalopram hydrobromide was administered with empty stomach by randomized crossover way in 24 healthy male volunteers.The chewable tablet was swallowed after been chewed for 30~60 s,while the referenced tablet was administered with warm water of 200 mL.The concentrations of the citalopram in plasma were detected by LC-MS/MS method.Results The main pharmacokinetics parameters of the chewable tablets and the referenced tablets were as follows:Cmax(16.56±4.12)vs.(18.30±4.72)μg/L,Tmax(4.42±2.41)vs.(5.00±2.87)h,t1/2(47.44±7.74)vs.(48.43±14.56)h,AUC0-tn(819.74±261.18)vs.(885.38±216.22)μg · h/L,AUC0-∞(939.00±336.16)vs.(1016.04±315.32)μg · h /L.The relative bioavailability F0-tn、F0-∞ of the citalopram hydrobromide chewable tablet were 91.92%±15.10% and 92.09%±15.52% respectively.Conclusion There are bioequivalence between domestic-made chewable tablets and imported tablets of citalopram hydrobromide.
Publication Year: 2011
Publication Date: 2011-01-01
Language: en
Type: article
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