Shandong Runhua Jirentang Pharmaceutical Co. Ltd.

The pharmacokinetic characteristics of butylphthalide soft capsules (test formulation, specification: 0.1g) provided by Huaxia Guoyao (Heze) Pharmaceutical Co., Ltd., and butylphthalide soft capsules (reference formulation, trade name: Enbipu®, specification: 0.1g) produced by CSPC Enbipu Pharmaceutical Co., Ltd., were examined under fasting conditions in healthy trial participants. The bioequivalence and safety between the two formulations were evaluated to provide a basis for the registration application of the test formulation.

This study investigated the pharmacokinetic characteristics of a single oral dose of tetraene-menaquinone soft capsules (test formulation, strength: 15 mg) provided by Huaxia Guoyao (Heze) Pharmaceutical Co., Ltd., or tetraene-menaquinone soft capsules (reference formulation, trade name: Gulikang®, strength: 15 mg) certified by Eisai Co., Ltd., in healthy study participants under fasting and postprandial conditions. The study aimed to evaluate the bioequivalence and safety of the two formulations and provide a basis for the registration application of the test formulation.