Hebei Longhai Pharmaceutical Co. Ltd.

Acetylcysteine effervescent tablets (specification: 0.6g) produced by Hebei Longhai Pharmaceutical Co., Ltd. were used as the test preparation, and acetylcysteine effervescent tablets (Fluluc®, specification: 0.6g) produced by ZAMBON S.P.A. (Italy) were used as the reference preparation. According to the relevant provisions of bioequivalence studies, the in vivo blood concentrations and main pharmacokinetic parameters of acetylcysteine effervescent tablets were compared in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, and the bioequivalence of the two preparations was evaluated.

Primary objective: Using bisoprolol amlodipine tablets [specification: bisoprolol fumarate 5 mg, amlodipine besylate (calculated as amlodipine) 5 mg] produced by Hebei Longhai Pharmaceutical Co., Ltd. as the test preparation, Merck Kft (Merck) as the marketing authorization holder, and bisoprolol amlodipine tablets [specification: bisoprolol fumarate 5 mg, amlodipine besylate (calculated as amlodipine) 5 mg; trade name: Kangxinan®] produced by Egis Pharmaceuticals PLC (Egis Pharmaceuticals) as the reference preparation, to compare the in vivo blood concentration and main pharmacokinetic parameters of bisoprolol amlodipine tablets in Chinese healthy subjects after a single oral administration in both fasting and postprandial states, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of bisoprolol amlodipine tablets test preparation or reference preparation in Chinese healthy subjects after a single oral administration in both fasting and postprandial states.

To evaluate the pharmacokinetic characteristics of the test preparation agomelatine tablets T [specification: 25 mg/tablet, produced by Hebei Longhai Pharmaceutical Co., Ltd.] and the reference preparation agomelatine tablets R [specification: 25 mg/tablet, produced by Les Laboratoires Servier Industrie and certified by Les Laboratoires Servier] in healthy adult Chinese subjects after a single oral administration of 25 mg in fasting and fed states, respectively, and to assess the bioequivalence of the two preparations after oral administration in fasting and fed states, respectively.