Zhejiang Dier Pharmaceutical Co., Ltd.

Primary objective: To observe the pharmacokinetic characteristics of the test formulation flunarizine hydrochloride capsules (5 mg, C26H26F2N2; manufactured by Zhejiang Dier Pharmaceutical Co., Ltd.); and the reference formulation flunarizine hydrochloride capsules (trade name: Sibelium®; 5 mg, C26H26F2N2; manufacturer and licensee: Xian Janssen Pharmaceutical Co., Ltd.) after a single oral administration in fasting conditions in healthy participants of the Chinese health trial. This preliminary evaluation of the bioequivalence of the two formulations under fasting conditions will provide a basis for the formal trial. Secondary objective: To observe the safety of the test formulation flunarizine hydrochloride capsules and the reference formulation flunarizine hydrochloride capsules (Sibelium®) in healthy participants of the Chinese health trial.

Main research purpose: According to the relevant provisions of bioequivalence test, ibuprofen suspension (trade name: Meilin, specification: 100 ml: 2 g) of Shanghai Johnson Pharmaceutical Co., Ltd. was selected as the reference preparation, and the test preparation ibuprofen suspension (specification: 100 ml: 2 g) produced by Zhejiang Deer Pharmaceutical Co., Ltd. was conducted on the human bioequivalence test of fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation ibuprofen suspension (specification: 100 ml: 2 g) and the reference preparation ibuprofen suspension (trade name: Meilin, specification: 100 ml: 2 g) by healthy volunteers.

Diclofenac sodium sustained-release tablets (specification: 0.1 g) produced by Zhejiang Deer Pharmaceutical Co., Ltd. were used as the test preparation, and diclofenac sodium sustained-release tablets (trade name: Voltaren® Retard, specification: 0.1 g) certified by Novartis Pharma Schweiz AG were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.