[Translation] Single center, randomized, open, single fasting subcutaneous administration, two preparations, two sequences, two cycles, crossover study of recombinant human parathyroid hormone for injection (1-84) and Natpar® in Chinese healthy subjects Comparative study on pharmacokinetics and safety
主要目的:观察中国健康受试者单次皮下注射试验药注射用重组人甲状旁腺素(1-84)(规格:100μg/瓶;生产厂家:四川泸州步长生物制药有限公司)和参照药重组人甲状旁腺素(1-84)(商品名:Natpar®,规格:50μg/剂;生产厂家:Shire Pharmaceuticals Ireland Limited)后的药代动力学特征,评价两种制剂的药代动力学相似性。
次要目的:
1.观察试验药重组人甲状旁腺素(1-84)和参照药Natpar®在中国健康受试者中的安全性;
2.观察试验药重组人甲状旁腺素(1-84)和参照药Natpar®在中国健康受试者中的免疫原性;
3.观察试验药重组人甲状旁腺素(1-84)和参照药Natpar®在中国健康受试者中单次皮下注射50μg后,血清总钙(白蛋白校正)浓度的变化。
[Translation] Main purpose: To observe the single subcutaneous injection of the experimental drug recombinant human parathyroid hormone (1-84) for injection (specification: 100μg/bottle; manufacturer: Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.) and the reference drug in Chinese healthy subjects. Pharmacokinetic characteristics of recombinant human parathyroid hormone (1-84) (trade name: Natpar®, specification: 50 μg/dose; manufacturer: Shire Pharmaceuticals Ireland Limited), and the pharmacokinetics of the two preparations are similar sex.
Secondary purpose:
1. Observe the safety of the experimental drug recombinant human parathyroid hormone (1-84) and the reference drug Natpar® in Chinese healthy subjects;
2. Observe the immunogenicity of the experimental drug recombinant human parathyroid hormone (1-84) and the reference drug Natpar® in Chinese healthy subjects;
3. To observe the change of serum total calcium (albumin correction) concentration after a single subcutaneous injection of 50 μg of the experimental drug recombinant human parathyroid hormone (1-84) and the reference drug Natpar® in Chinese healthy subjects.