Shanxi Sanjiu Tongda Pharmaceutical Co. Ltd.

Main study objectives To study the pharmacokinetics of the test preparation amoxicillin capsule (specification: 0.5g, manufacturer: Shanxi Tongda Pharmaceutical Co., Ltd.) and the reference preparation amoxicillin capsule (trade name: Clamoxyl®, specification: 500mg, licensee: GlaxoSmithKline S.A) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation (T) amoxicillin capsule and the reference preparation (R) amoxicillin capsule (Clamoxyl®) after a single oral administration in healthy subjects after a meal.

The main purpose of the study was to use the bisoprolol amlodipine tablets owned by Shanxi Tongda Pharmaceutical Co., Ltd. as the test preparation and the bisoprolol amlodipine tablets (trade name: Kangxinan®, specifications: bisoprolol fumarate 5 mg and amlodipine besylate (calculated as amlodipine) 5 mg) licensed by Merck Kft as the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions through a single-center, randomized, open, single-dose, two-sequence, two-period, double-crossover clinical study. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation in Chinese health research participants.

Main study objectives To study the pharmacokinetics of the test preparation amoxicillin capsule (specification: 0.5g, manufacturer: Shanxi Tongda Pharmaceutical Co., Ltd.) and the reference preparation amoxicillin capsule (trade name: Clamoxyl®, specification: 500mg, licensee: GlaxoSmithKline S.A) in healthy adult subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation (T) amoxicillin capsule and the reference preparation (R) amoxicillin capsule (Clamoxyl®) after a single oral administration under fasting conditions in healthy subjects.