1. Bioequivalence study of cinacalcet hydrochloride tablets in healthy Chinese volunteers
Qiangyong YAN ; Daxiong XIANG ; Ronghua ZHU ; Xiding YANG ; Jingjing LI ; Xiao FAN ; Pingfei FANG ; Qiangyong YAN ; Daxiong XIANG ; Ronghua ZHU ; Lingfeng YANG ; Xiding YANG ; Jingjing LI ; Xiao FAN ; Pingfei FANG ; Lingfeng YANG ; Sai LIU ; Shoujun XIONG
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(2):171-177
AIM: To evaluate the bioequivalence of cinacalcet hydrochloride tablets in healthy Chinese volunteers. METHODS: A randomized, open, double-period and crossover trial was conducted, 48 healthy volunteers were administered a single dose of cinacalcet test tablets or reference tablets orally under each fasting and fed condition. The concentration of cinacalcet was determined by validated LC-MS/MS method. Pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 to study its bioequivalence. RESULTS: The main pharmacokinetic parameters of test tablets and reference tablets under fasting condition were as follows: C
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