Suzhou Pharma Services

Using Anacor Pharmaceuticals, Inc.'s crisaborole ointment (2%, trade name Staquis®) as the reference preparation and Suzhou Tianma Pharmaceutical Group Tianji Biopharmaceutical Co., Ltd.'s crisaborole ointment (2%) as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-cycle, two-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects. Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects; 2) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.

Main research purpose: To study the pharmacokinetic characteristics of a single oral administration of metformin empagliflozin tablets (test preparation, specification: each tablet contains 1000mg of metformin hydrochloride and 5mg of empagliflozin) provided by Suzhou Tianma Pharmaceutical Group Tianji Biopharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of metformin empagliflozin tablets (reference preparation, trade name: Synjardy®, specification: each tablet contains 1000mg of metformin hydrochloride and 5mg of empagliflozin) certified by Boehringer Ingelheim Pharmaceuticals Inc under the same conditions, to evaluate the bioequivalence between the two preparations, and to provide a basis for the registration application of the test preparation. Secondary study objectives: To observe the safety of a single oral administration of one tablet of the test preparation metformin empagliflozin tablet (specification: each tablet contains 1000 mg of metformin hydrochloride and 5 mg of empagliflozin) and one tablet of the reference preparation metformin empagliflozin tablet (trade name: Synjardy®, specification: each tablet contains 1000 mg of metformin hydrochloride and 5 mg of empagliflozin) to healthy subjects under fasting and postprandial conditions.

To investigate the bioequivalence and safety of a single oral administration of rebamipide tablets (test preparation T, strength: 100 mg) produced by Suzhou Tianma Pharmaceutical Group Tianji Biopharmaceutical Co., Ltd. and Jiangsu Pegasus Pharmaceutical Co., Ltd. and rebamipide tablets (reference preparation R, trade name: Mucosta®, strength: 100 mg) produced by OTSUKA PHARMACEUTICAL Co., Ltd in healthy Chinese subjects under fasting and postprandial conditions.