Jiangxi Shanxiang Pharm Co. Ltd.

Main purpose: To evaluate the effectiveness of relugolix tablets (specification: 120 mg) developed by Jiangxi Shanxiang Pharmaceutical Co., Ltd. in the treatment of androgen-sensitive advanced prostate cancer, using serum testosterone continuous castration rate as the main evaluation index. Secondary purpose: To evaluate the safety and other efficacy indicators of relugolix tablets (specification: 120 mg) in the treatment of androgen-sensitive advanced prostate cancer.

Primary objective: To investigate the pharmacokinetic characteristics of mesalazine after a single oral administration of the mesalazine sustained-release granules test formulation (specification: 1g, manufacturer: Jiangxi Shanxiang Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Pentasa®, specification: 1g, licensee: Ferring S.A.S) to healthy Chinese subjects under fasting and postprandial conditions, and to evaluate whether the two formulations are bioequivalent under fasting and postprandial conditions. Secondary objective: To evaluate the safety of the mesalazine sustained-release granules test formulation (specification: 1g) and the reference formulation (trade name: Pentasa®, specification: 1g) in healthy subjects.

"Main study objectives: To investigate the pharmacokinetic characteristics of the test preparation T (produced by Jiangxi Shanxiang Pharmaceutical Co., Ltd., specification: 120 mg) and the reference preparation R (licensed by Myovant Sciences GmbH, trade name: ORGOVYX®, specification: 120 mg) of relugolix tablets in healthy subjects after a single dose under fasting and postprandial conditions, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary study objectives: To observe the safety of the test preparation and the reference preparation in healthy subjects."