Non-Compartmental Pharmacokinetics and Safety of Single-Dose Eldecalcitol (ED-71) in Healthy Chinese Adult Males

ConclusionPharmacokinetic exposure (Cmax and partial AUCs) was dose-proportional over the tested dose range of 0.5 –0.75 µg in healthy Chinese adult males. The pharmacokinetic character of eldecalcitol in Chinese subjects was similar to historical data from Japanese subjects. Eldecalcitol was well tolerated at doses ranging from 0.5 to 0.75 µg, with no new safety signals identified.Clinical Trial RegistrationThis study was registered at the China Food and Drug Administration (Registration number: 2014L02212 and 2014L02213), and also registered athttp://www.chinadrugtrials.org.cn (No. CTR20160430).
Source: Clinical Drug Investigation - Category: Drugs & Pharmacology Source Type: research