Pharmacokinetics and Bioequivalence of Domestic Citalopram Hydrobromide Tablet in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To compare the pharmacokinetics and bioavailability between domestic(test)and imported(reference)citalopram hydrobromide tablets and to evaluate the bioequivalence of the two preparations.METHODS:A single dose of 40 mg test tablet or reference tablet of citalopram hydrobromide was administered by randomized crossover way in 20 healthy male volunteers and the plasma concentrations of the citalopram hydrobromide were determined by HPLC.The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioavailability was evaluated.RESULTS:The concentration-time curves of two preparations fitted two compartment mode1.The pharmacokinetic parameters of the test preparation versus the reference preparation were as follows,Cmax:(147.00?86.04)ng?mL-1 vs.(154.13?87.57)ng?mL-1;tmax:(4.55?1.35)h vs(4.75?1.65)h;AUC0～196:(6 590.69 ? 1 866.00)ng?h?mL-1 vs.(7 156.26?2 181.18)ng?h?mL-1;AUC0～∞:(7 767.56?2 193.92)ng?h?mL-1 vs.(8 433.45?2 631.88)ng?h?mL-1.The relative bioavailability of the test citalopram hydrobromide tablet was(92.10?18.68)%.CONCLUSION:The domestic and the reference citalopram hydrobromide tablet are bioequivalent.