Suzhou Pharmaceutical Factory

Main research purpose: According to the relevant provisions of bioequivalence test, Aspen Pharmacare Australia Pty Ltd was selected as the reference preparation for the test preparation of leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg) provided by Suzhou Pharmaceutical Factory of Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. The human bioequivalence test of fasting administration was carried out 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 administration conditions. Secondary research purpose: To observe the safety of the test preparation leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg) and the reference preparation leprocaine cream (trade name: EMLA; specification: 1g: lidocaine 25mg, prilocaine 25mg) applied externally to healthy subjects.

Main study objectives To study the pharmacokinetics of Eperisone Hydrochloride Tablets (Specification: 50mg) produced by Suzhou Pharmaceutical Factory of Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. and Eperisone Hydrochloride Tablets (Miao Na®, Specification: 50mg) certified by Eisai (China) Pharmaceutical Co., Ltd. in healthy adult subjects under the conditions of single administration on an empty stomach and after a meal, and to evaluate the bioequivalence of the two preparations when taken orally in the empty stomach and after a meal. Secondary study objectives To evaluate the safety of the test preparation Eperisone Hydrochloride Tablets (Specification: 50mg) and the reference preparation Eperisone Hydrochloride Tablets (Miao Na®, Specification: 50mg) when taken orally in a single dose in healthy adult subjects.

Primary objective: Carbazochrome sodium sulfonate tablets from Suzhou Pharmaceutical Factory of Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. were used as the test preparation, and carbazochrome sodium sulfonate tablets from Nipro ES Pharmaceutical Co., Ltd. were used as the reference preparation. The bioequivalence of the two preparations in fasting and postprandial states was evaluated by a single-center, randomized, open, single-dose, two-period, double-crossover design. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.