Jiangsu Ducheng Pharmaceuticals Co., Ltd.

The pharmacokinetic characteristics of minodronic acid tablets produced by Jiangsu Ducheng Pharmaceutical Technology Co., Ltd. were studied in healthy Chinese volunteers after single and multiple oral administration, in order to provide a basis for clinical medication.

Main research purpose: Using minodronic acid tablets (trade name: Bonoteo, specifications: 1 mg/tablet) produced by Aisu Rakusu Co., Ltd. as the reference preparation, and using minodronic acid tablets (minodronic acid tablets) developed by Jiangsu Ducheng Pharmaceutical Technology Co., Ltd. Specification: 1 mg/tablet) is the test preparation. The bioequivalence of the two preparations in Chinese healthy subjects under fasting state was evaluated. Secondary research purpose: To observe the safety of the test preparation minodronic acid tablets (specification: 1mg/tablet) and the reference preparation minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) orally administered to Chinese healthy subjects sex.

The placebo-controlled, lumbar spine average bone density change rate was used as the primary efficacy indicator to evaluate the efficacy and safety of minodronic acid tablets in the treatment of osteoporosis in postmenopausal women, providing a clinical basis for registration.