Tian Jin Heng Yi Yao Ye You Xian Gong Si

Main purpose: Through a small sample size pilot study, to investigate the similarity between a single oral dose of L-glutamine sodium guarenate granules (specification: 0.67g (L-glutamine 663.3mg, sodium guarenate 2.0mg)/bag) produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. and L-glutamine sodium guarenate granules (trade name: MARZULENE-S®, specification: 0.67g (L-glutamine 663.3mg, sodium guarenate 2.0mg)/bag) produced by the licensed manufacturer Kotobuki Pharmaceutical Co., Ltd. in Chinese healthy subjects under fasting conditions, to investigate the in vivo pharmacokinetic characteristics of the drug, to provide a decision-making basis for whether to enter the formal trial, and to verify the rationality of the formal trial sample size, blood collection points, test cycle intervals and analysis methods. Secondary objective: To evaluate the safety of a single-dose oral L-glutamine sodium guarenate granules test formulation (specification: 0.67 g (L-glutamine 663.3 mg, sodium guarenate 2.0 mg)/bag) and reference formulation (trade name: MARZULENE-S®, specification: 0.67 g (L-glutamine 663.3 mg, sodium guarenate 2.0 mg)/bag) in healthy Chinese subjects.

Primary objective: To investigate the in vivo pharmacokinetic characteristics of the test preparation (Betahistine Mesylate Tablets, Tianjin Hengyi Pharmaceutical Co., Ltd.) and the reference preparation (Betahistine Mesylate Tablets, trade name: Minshilan®, Eisai (China) Pharmaceutical Co., Ltd.) in healthy Chinese subjects after a single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and the reference preparation of Betahistine Mesylate Tablets (6 mg) taken orally in healthy Chinese subjects.

Primary objective: To investigate the in vivo pharmacokinetic characteristics of bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. (holder: Tianjin Hengyi Pharmaceutical Co., Ltd.) and bisoprolol amlodipine tablets (trade name: Kangxinan®, specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) produced by Merck Kft. under fasting/postprandial conditions in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of a single-dose oral bisoprolol amlodipine tablet test formulation (specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) and a reference formulation (trade name: Kangxinan®, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) in healthy Chinese subjects.