Shanghai Xudong Haipu Pharmaceutical Co., Ltd.

Primary objectives: 1) To evaluate the safety and tolerability of a single intravenous administration of GPN00068 injection in healthy subjects; 2) To evaluate the pharmacokinetic characteristics of a single intravenous administration of GPN00068 injection in healthy subjects; Secondary objectives: 1) To identify metabolites in vivo after a single intravenous administration of GPN00068 injection in healthy subjects; 2) To preliminarily evaluate the cumulative excretion rate of GPN00068 injection in urine after a single intravenous administration in healthy Chinese subjects.

Primary objective: To use Macitentan Tablets (Specification: 10 mg) developed by Shanghai Xudong Haipu Pharmaceutical Co., Ltd. as the test preparation and Macitentan Tablets (Trade name: Apoquel®, Specification: 10 mg) developed by Actelion Pharmaceuticals Ltd. as the reference preparation, to investigate the pharmacokinetic parameters of the two preparations in the fasting and postprandial state after a single dose, and to evaluate whether the two preparations are bioequivalent. Secondary objective: To evaluate the safety of Macitentan Tablets (10 mg) produced by Shanghai Xudong Haipu Pharmaceutical Co., Ltd.

To investigate the pharmacokinetic parameters of macitentan tablets (10 mg) produced by Shanghai Xudong Haipu Pharmaceutical Co., Ltd. and macitentan tablets (Oposu®, 10 mg) produced by Actelion Pharmaceuticals Ltd., verify the rationality of the blood drug concentration analysis method and the settings of blood sampling time, sampling volume, time interval, etc., preliminarily evaluate the bioequivalence of the two preparations and calculate the intra-individual coefficient of variation. To evaluate the safety of macitentan tablets (10 mg) produced by Shanghai Xudong Haipu Pharmaceutical Co., Ltd.