Xi'an Gelan Xintong Pharmaceutical Co., Ltd.

According to the requirements of the drug clinical research approval certificate (approval number: 2015L00491) issued by the State Food and Drug Administration, a human bioequivalence study was conducted on amlodipine besylate tablets. Amlodipine besylate tablets (trade name: Norvasc) produced by Pfizer Pharmaceuticals, Inc. of the United States were selected as the reference preparation. Human bioavailability and bioequivalence tests were conducted, the relative bioavailability of the test preparation was calculated, and the bioequivalence of the two preparations was compared.

Primary objectives: (1) To evaluate the safety and tolerability of single and multiple doses of XT1061 in healthy subjects under fasting conditions; (2) To evaluate the pharmacokinetic effects of single and multiple doses of XT1061 in healthy subjects under fasting conditions; (3) To evaluate the effect of food on the pharmacokinetics of XT1061 in healthy subjects. Secondary objectives: (1) To preliminarily explore the metabolic transformation of XT1061 in healthy subjects after single doses of XT1061 under fasting conditions; (2) To evaluate the effect of a high-fat diet on the safety of XT1061 in healthy subjects.

Primary objective: To evaluate the bioequivalence of moxifloxacin hydrochloride tablets (specification: 0.4 g/tablet) produced by Xi'an Gelanxintong Pharmaceutical Co., Ltd. and moxifloxacin hydrochloride tablets (specification: 0.4 g/tablet, trade name: Bayer®, manufacturer: Bayer Pharma AG) produced by Bayer Vital GmbH in Chinese healthy subjects after single oral administration under fasting and fed conditions. Secondary objective: To evaluate the safety of moxifloxacin hydrochloride tablets in Chinese healthy subjects.