Pharmacokinetics and bioequivalence of citric acid tamoxifen dispersible tablet in healthy volunteers

Abstract

Abstract: AIM: To study the pharmacokinetics and relative bioavailability of citric acid tamoxifen dispersible tablet in Chinese healthy volunteers. METHODS: In a randomized two period crossover study, 20 healthy volunteers received tested and reference tablets 20 mg.The plasma concentrations of tamoxifen were determined by HPLC.The pharmacokinetics of tamoxifen was estimated by the non-compartment model. RESULTS: The main pharmacokinetics parameters of tested and reference tablets were as the following:tmax (6.3±2.2), (6.7±2.4)h;Cmax (72±14), (68± 16) μg/L;AUC(0-492)(4.6±2.0), (4.6 ±2.0) mg·L-1 h;t12(143±24), (153±33)h, respectively.The relative bioavailability was (101±13)%. CONCLUSION: The two formulations are bioequivalent in human.

Key words: tamoxifen, HPLC-FLU, pharmacokinetics, bioequivalence

CLC Number:

R969.1

ZHANG Qian, ZHU Yu-bing, YU Cui-xia, ZOU Jian-jun, LU Tao, XIAO Da-wei, ZHUDong-ya. Pharmacokinetics and bioequivalence of citric acid tamoxifen dispersible tablet in healthy volunteers[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(3): 303-308.

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