Zhejiang Yake Pharmaceutical Co. Ltd.

Primary Objective: In accordance with relevant bioequivalence testing regulations, calcitriol soft capsules (trade name: Rocaltrol®; specification: 0.5 μg/capsule), manufactured by Atnahs Pharma Switzerland AG, was selected as the reference formulation. A preliminary human bioequivalence study was conducted on the test formulation calcitriol soft capsules (specification: 0.5 μg/capsule) produced by Zhejiang Zhebei Pharmaceutical Co., Ltd. and provided by Zhejiang Yake Pharmaceutical Co., Ltd., under fasting administration. The study aimed to compare the likelihood of bioequivalence between the test and reference formulations under fasting administration conditions, providing a reference for the design of the formal trial. Secondary Objective: To observe the safety of oral administration of the test formulation calcitriol soft capsules (specification: 0.5 μg/capsule) and the reference formulation calcitriol soft capsules (trade name: Rocaltrol®; specification: 0.5 μg/capsule) to healthy volunteers.

(1) Primary objective: To observe the tolerability and safety of this product in patients with advanced solid tumors whose condition is stable after conventional treatment through a dose escalation trial, and to recommend a safe dose for Phase II clinical trials. (2) Secondary objective: To evaluate the pharmacokinetic characteristics and dose-effect relationship (PK/PD) of this product.

(1) To explore the effectiveness of Yijinsheng Capsules in treating fatigue (Qi deficiency syndrome) after adjuvant chemotherapy after lung cancer surgery; (2) To preliminarily observe the safety of Yijinsheng Capsules in clinical use.