Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

The bioequivalence of the test preparation, sodium valproate extended-release tablets (I) [Specification: 0.5 g, licensee: Randian (Nanjing) Biopharmaceutical Technology Co., Ltd.] and the reference preparation, sodium valproate extended-release tablets (I) (Depakin®, specification: 0.5 g), licensee: Sanofi (Hangzhou) Pharmaceutical Co., Ltd., was evaluated in healthy male and female subjects under fasting/postprandial conditions.

Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of plasma concentrations of etomidate in healthy subjects after administration of etomidate medium/long-chain emulsion injection developed by Randian (Nanjing) Biopharmaceutical Technology Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. The etomidate medium/long-chain emulsion injection [trade name: Itoli®] produced by B. Braun Melsungen AG was used as a reference to investigate the bioavailability of the test preparation, evaluate the bioequivalence between the preparations, and observe the safety of etomidate medium/long-chain emulsion injection in healthy Chinese subjects.

Main purpose of the study: To investigate the pharmacokinetic characteristics of a single oral administration of nifedipine controlled-release tablets (test preparation, specification: 30 mg) provided by Randian (Nanjing) Biopharmaceutical Technology Co., Ltd. under fasting and postprandial conditions and a single oral administration of nifedipine controlled-release tablets (reference preparation, trade name: Bayer Pharma AG, specification: 30 mg) produced by Bayer Pharma AG under the same conditions, to evaluate the bioequivalence of the two preparations in healthy humans, and to provide a basis for the registration application of the test preparation. Secondary purpose of the study: To observe the safety of a single oral administration of 30 mg of the test preparation nifedipine controlled-release tablets (specification: 30 mg) and the reference preparation nifedipine controlled-release tablets (trade name: Bayer Pharma, specification: 30 mg) in healthy subjects under fasting and postprandial conditions.