Kananji Pharmaceutical Technology (Shanghai) Co., Ltd.

This study aims to investigate the in vivo absorption, material balance and biotransformation pathways of [14C] CM082 after a single oral dose in healthy Chinese male subjects, so as to evaluate the overall pharmacokinetic characteristics and safety of CM082 in humans and provide a reference for the rational clinical use of the drug.

The primary objective was to use CM082 tablets, which were improved by Betta Pharmaceuticals Co., Ltd., the parent company of Kananji Pharmaceuticals (Shanghai) Co., Ltd., as the test preparation and CM082 tablets produced by the original process as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of CM082 tablets in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations. The secondary objective was to evaluate the safety of the test preparation and the reference preparation of CM082 tablets after a single oral administration on an empty stomach or after a meal in healthy Chinese subjects.

The primary objective is to evaluate the effect of food on the pharmacokinetic characteristics of CM082 tablets in healthy Chinese subjects, and to provide a basis for subsequent clinical trials, drug registration and clinical use. The secondary objective is to evaluate the safety of a single oral administration of CM082 tablets in healthy Chinese subjects.