Xinkai Medicine and Chemical Intermediates (Shanghai) Co., Ltd.

A single-center, randomized, open, single-dose, parallel trial design was used to compare the differences in the degree and rate of absorption of teriflunomide tablets (specification: 14 mg) provided by Suzhou Changzheng-Xinkai Pharmaceutical Co., Ltd. and teriflunomide tablets (specification: 14 mg, trade name: Aubagio®) licensed by Sanofi Aventis U.S. Inc. in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of teriflunomide tablets provided by Suzhou Changzheng-Xinkai Pharmaceutical Co., Ltd.

Main study objectives To determine the safety, tolerability and recommended dose (RP2D) of CK21 in patients with advanced malignant solid tumors. Secondary study objectives (1) To determine the pharmacokinetic and pharmacodynamic characteristics of CK21 in patients with advanced malignant solid tumors. (2) To evaluate the preliminary efficacy of CK21 in patients with advanced malignant solid tumors. Exploratory study objectives (1) To explore the levels of potential biomarkers predicting efficacy and their relationship with efficacy. (2) To explore and analyze the relationship between PK and pharmacodynamics.

Hydroxychloroquine sulfate tablets (specification: 200 mg) produced by Suzhou Changzheng Xinkai Pharmaceutical Co., Ltd. were used as the test preparation, and hydroxychloroquine sulfate tablets (specification: 0.2 g, trade name: PLAQUENIL®) certified by Aventis Pharma Limited were used as the reference preparation. A single-center, randomized, open, single-dose, single-period parallel trial design clinical study was conducted to evaluate the bioequivalence of the two preparations in humans under fasting and fed conditions.