Feifei Sun, Yanping Liu, Ting Li, Pingping Lin, Xin Jiang, Xin Li, Chenjing Wang, Xiaomeng Gao, Yaping Ma, Yao Fu, Yu Cao
BACKGROUND: Ezetimibe is a new class of antihyperlipidemic agent indicated for the prevention of atherosclerosis disease and for the treatment of hypercholesterolemia. Information on the pharmacokinetic profiles of ezetimibe tablet in healthy Chinese volunteers are lacking, and regulatory requirements necessitate a bioequivalence study of ezetimibe tablet versus Ezetrol® in China. METHODS: A single-dose randomized, open-label, two-group, two-period crossover study was conducted in 59 healthy Chinese volunteers under fasting or fed conditions to assess the bioequivalence between two preparations...
February 3, 2023: BMC Pharmacology & Toxicology