Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

Primary objective: To investigate the in vivo pharmacokinetic characteristics of dronedarone hydrochloride tablets (specification: 400 mg/tablet) produced and owned by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. and dronedarone hydrochloride tablets (trade name: Multaq®, specification: 400 mg/tablet) licensed by Sanofi Aventis U.S., LLC in healthy Chinese male subjects after 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 and reference preparations of dronedarone hydrochloride tablets in healthy Chinese male subjects after single oral administration.

Main research purpose: According to the relevant provisions of bioequivalence test, metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) of MERCK SANTE s.a.s. as the licensee were selected as the reference preparation, and the test preparation metformin hydrochloride tablets (specification: 0.85g) produced and provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. were conducted on the fasting human bioequivalence test, 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 conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation metformin hydrochloride tablets (specification: 0.85g) and the reference preparation metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) by healthy subjects.

Main research purpose: According to the relevant provisions of bioequivalence test, metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) of MERCK SANTE s.a.s. as the licensee were selected as the reference preparation, and the test preparation metformin hydrochloride tablets (specification: 0.85g) produced and provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. were subjected to postprandial human bioequivalence test, 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 postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation metformin hydrochloride tablets (specification: 0.85g) and the reference preparation metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) by healthy subjects.