Beijing Kangerfu Pharmaceutical Co., Ltd.

Primary study objective: To evaluate the bioequivalence of single fasting and single postprandial administration of calcium dobesilate tablets 0.25 g (specification: 0.25 g/tablet; test preparation) produced by Ningxia Kangya Pharmaceutical Co., Ltd. and calcium dobesilate tablets 250 mg (trade name: Doxium; specification: 250 mg/tablet; reference preparation) produced by OM pharma S.A. in healthy Chinese subjects; Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

In healthy subjects, the absorption rate and extent of Saxagliptin Metformin Sustained-Release Tablets (I) developed by Beijing Kangerfu Pharmaceutical Co., Ltd. were studied under fasting and postprandial conditions, using Saxagliptin Metformin Sustained-Release Tablets (I) owned by AstraZeneca AB as the reference preparation, and the bioequivalence of the test preparation and the reference preparation was evaluated. The safety of the test preparation and the reference preparation when taken orally in healthy subjects was observed.

Primary objective: Compare the overall survival (OS) of the subjects in the icariin group and the cinobucini group. Secondary objectives: Compare the 9/12/18-month OS rate, time to disease progression (TTP), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) between the two groups of subjects; Compare the time to quality of life deterioration (TTD) between the two groups of subjects, including health-related quality of life/general health status (HRQoL/GHS), physical function, role function and symptoms; Compare the safety and tolerability of the two groups of subjects; Conduct a population pharmacokinetic (PopPK) exploratory study to evaluate the pharmacokinetic (PK) characteristics of icariin after administration and its influencing factors, and explore the relationship between exposure and efficacy. Exploratory purpose: Explore the correlation between peripheral blood biomarkers and clinical efficacy at the protein level and genomic (DNA, RNA) level to support companion diagnosis and precision treatment of subjects; Explore the genomic information of subjects in PopPK studies, including the genotype of metabolic enzyme uridine diphosphate glucosyltransferase (UGTs), the correlation between the genotype of transporters such as multidrug resistance-associated protein 2 (MRP2), multidrug resistance 1 (MDR1), breast cancer resistance protein (BCRP), organic anion transporter 3 (OAT3) and PK characteristics; and the correlation between drug exposure level and efficacy.