Chongqing Shisen Pharmaceutical Technology Co. Ltd.

Main research purpose: According to the relevant provisions of bioequivalence test, L-glutamine sodium guarenate granules (trade name: Marzulene-S, specification: 0.67g: L-glutamine 663.3mg, sodium guarenate 2.0mg) of Kotobuki Pharmaceutical Co., Ltd. as the licensee were selected as the reference preparation, and the L-glutamine sodium guarenate granules (specification: 0.67g: L-glutamine 663.3mg, sodium guarenate 2.0mg) provided by Chongqing Shisen Pharmaceutical Technology Co., Ltd. were used for fasting and fed human bioequivalence preliminary test, and the pharmacokinetic behavior of the two preparations in healthy Chinese volunteers was compared to evaluate the possibility of bioequivalence of the two preparations under fasting and fed conditions. Secondary study objective: To observe the safety of oral administration of the test preparation L-glutamine sodium guarenate granules (specification: 0.67g: L-glutamine 663.3mg, sodium guarenate 2.0mg) and the reference preparation L-glutamine sodium guarenate granules (trade name: Marzulene-S, specification: 0.67g: L-glutamine 663.3mg, sodium guarenate 2.0mg) in healthy volunteers.

Main research purpose: According to the relevant provisions of bioequivalence test, vitamin K1 injection (trade name: Konakion® MM 10mg, specification: 1mL:10mg) with a license holder of Cheplapharm Arzneimittel GmbH was selected as the reference preparation, and the test preparation vitamin K1 injection (specification: 1mL:10mg) produced by Guangdong Xinghao Pharmaceutical Co., Ltd. and provided by Chongqing Shisen Pharmaceutical Technology Co., Ltd. was subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. At the same time, the safety of oral administration of the test preparation vitamin K1 injection (specification: 1mL:10mg) and the reference preparation vitamin K1 injection (trade name: Konakion® MM 10mg; specification: 1mL:10mg) was observed in healthy volunteers.

Main research purpose: According to the relevant provisions of bioequivalence test, Takeda Pharma A/S is the licensee of Asartan Potassium Tablets (trade name: Edabi®, specification: 80 mg) as the reference preparation, and the test preparation Asartan Potassium Tablets (specification: 80 mg) provided by Chongqing Shisen Pharmaceutical Technology Co., Ltd. is used for human bioequivalence test under fasting and postprandial administration conditions, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. At the same time, the safety of oral administration of the test preparation Asartan Potassium Tablets (specification: 80 mg) and the reference preparation Asartan Potassium Tablets (trade name: Edabi®, specification: 80 mg) in healthy subjects was observed.