Bioequivalence study of cinacalcet hydrochloride tablets in healthy Chinese volunteers

Author: Qiangyong YAN ¹ ; Daxiong XIANG ¹ ; Ronghua ZHU ¹ ; Xiding YANG ¹ ; Jingjing LI ¹ ; Xiao FAN ¹ ; Pingfei FANG ¹ ; Qiangyong YAN ² ; Daxiong XIANG ² ; Ronghua ZHU ² ; Lingfeng YANG ² ; Xiding YANG ² ; Jingjing LI ² ; Xiao FAN ² ; Pingfei FANG ² ; Lingfeng YANG ³ ; Sai LIU ⁴ ; Shoujun XIONG ⁴
Author Information

1. Department of Pharmacy, The Second Xiangya Hospital, Central South University
2. Phase l Clinical Trial Center, The Second Xiangya Hospital, Central South University
3. Department of Metabolism & Endocrinology, The Second Xiangya Hospital, Central South University
4. Nanjing Hencer Pharmaceutical Co., Ltd.
Publication Type:Journal Article
Keywords: bioequivalence; cinacalcet; LC-MS/ MS; pharmacokinetics
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(2):171-177
CountryChina
Language:Chinese
Abstract: 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