Teriparatide(Hybio)

In this study, teriparatide injection (specification: 20 μg: 80 μL, 2.4 mL/vial) produced by Shenzhen Hanyu Pharmaceutical Co., Ltd. was used as the test preparation, and teriparatide injection (trade name: Futaio®, specification: 20 μg: 80 μL, 2.4 mL/vial) produced by Lilly France (licensed by Eli Lilly Nederland B.V.) was used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation in healthy Chinese female subjects. The safety of the test preparation and the reference preparation in healthy Chinese female subjects was also observed.

Using the original drug teriparatide injection (trade name: FORTEO) as a positive control, the pharmacokinetic characteristics of subcutaneous teriparatide injection were analyzed, and an equivalent analysis was performed with the original drug. The efficacy and safety of subcutaneous teriparatide injection in the treatment of postmenopausal female patients with osteoporosis were evaluated.