Shenzhen Kangzhe Biotech Co., Ltd.

To evaluate the safety and tolerability of single or multiple oral administration of CMS-D002, the effect of food on the exposure of CMS-D002 after a single oral administration, the effect of once-daily oral administration of CMS-D002 combined with ABT on sex hormone levels for 4 weeks (28 days), and to determine the excretion extent of CMS-D002-related substances in urine and feces after a single oral administration.

Main study objectives This study investigates the pharmacokinetic characteristics of a single oral administration of ursodeoxycholic acid oral suspension (test preparation, specification: 250 mg/5 mL) produced by Dr. Falk Pharma GmbH and a single oral administration of ursodeoxycholic acid capsules (reference preparation, trade name: Ursofalk®, specification: 250 mg) produced by Dr. Falk Pharma GmbH under fasting or postprandial conditions in healthy subjects, and compares the bioavailability of the two, in order to provide a basis for the import registration application of the test preparation. Secondary study objectives To evaluate the safety of a single oral administration of the test preparation ursodeoxycholic acid oral suspension (specification: 250 mg/5 mL) or the reference preparation ursodeoxycholic acid capsules (trade name: Ursofalk ®, specification: 250 mg) under fasting or postprandial conditions in healthy subjects.

This study aims to evaluate the pharmacokinetic characteristics of a single oral dose of budesonide enteric-coated capsules (9 mg) in healthy Chinese adult male and female subjects in the fasting state and to evaluate the safety of budesonide enteric-coated capsules in the healthy Chinese population. This study adopts a single-dose, single-cycle, open-label design and is a human pharmacokinetic study of fasting administration.