Nanjing Jiuxiao Pharmaceutical Co., Ltd.

According to the relevant provisions of pharmacokinetic tests, the Alendronate Sodium Vitamin D3 Tablets (II) (trade name: Fumega®; specification: each tablet contains 70 mg of alendronate sodium (calculated as alendronic acid) and 5600 IU of vitamin D3 (equivalent to 140 μg)) produced by Hangzhou Merck Pharmaceutical Co., Ltd. was selected as the reference preparation, and the fasting oral bioequivalence test of the test preparation Alendronate Sodium Vitamin D3 Tablets (II) (specification: each tablet contains 70 mg of alendronate sodium (calculated as alendronic acid) and 5600 IU of vitamin D3 (equivalent to 140 μg)) held by Nanjing Jiuxiao Pharmaceutical Co., Ltd. was conducted to compare the time course of blood drug concentrations of the two preparations in Chinese healthy volunteers and estimate the corresponding pharmacokinetic parameters. At the same time, the safety of healthy subjects after oral administration of the test preparation and the reference preparation was observed.