Shanghai Pharma Rare Disease Medicine Co., Ltd.

According to the relevant provisions of bioequivalence tests, the penicillamine capsules (trade name: Cuprimine, specification: 250 mg) of which Valeant Pharmaceuticals International is the licensee was selected as the reference preparation. The test preparation penicillamine capsules (specification: 250 mg) produced by Shanghai SPH Xinyi Pharmaceuticals Co., Ltd. and licensed by Shanghai SPH Ruier Pharmaceuticals Co., Ltd. were subjected to a human bioequivalence test under fasting conditions. The pharmacokinetic parameters Cmax and AUC0-72h of the two preparations were compared to evaluate the human bioequivalence of the two preparations.

Primary objective: To compare the pharmacokinetic behavior of the test preparation, Macitentan Tablets (licensed by: Shanghai SPH Ruier Pharmaceutical Co., Ltd.) and the reference preparation, Macitentan Tablets (licensed by: Actelion Pharmaceuticals Ltd., trade name: Aposhu®) in healthy subjects after oral administration in the fasting/postprandial state, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation, Macitentan Tablets, and the reference preparation, Macitentan Tablets in healthy subjects.

The main purpose of the study is to use the Everolimus Tablets (trade name: Afinitor) licensed by Novartis Pharma Schweiz AG as the reference preparation and the Everolimus Tablets licensed by Shanghai Haiyao Ruier Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.