[Translation] A single-center, randomized, open-label, single fasting subcutaneous, two-dose, two-sequence, two-period, crossover pharmacokinetic comparability study of recombinant human parathyroid hormone (1-84) for injection before and after the change of production site in healthy Chinese subjects
主要目的:
评估生产场地变更前后的注射用重组人甲状旁腺素(1-84)[rhPTH(1-84),规格:100μg/瓶]在中国健康受试者中单次空腹皮下注射给药100μg的药代动力学相似性。
次要目的:
1. 观察生产场地变更前后的注射用重组人甲状旁腺素(1-84)在中国健康受试者中的安全性;
2. 观察生产场地变更前后的注射用重组人甲状旁腺素(1-84)在中国健康受试者中的免疫原性;
3. 观察生产场地变更前后的注射用重组人甲状旁腺素(1-84)在中国健康受试者中单次皮下注射100μg后,血清总钙(白蛋白校正)浓度的变化。
[Translation] Primary objective:
To evaluate the pharmacokinetic similarity of a single fasting subcutaneous injection of 100 μg of recombinant human parathyroid hormone (1-84) for injection [rhPTH (1-84), specification: 100 μg/bottle] in healthy Chinese subjects before and after the change of production site.
Secondary objectives:
1. To observe the safety of recombinant human parathyroid hormone (1-84) for injection in healthy Chinese subjects before and after the change of production site;
2. To observe the immunogenicity of recombinant human parathyroid hormone (1-84) for injection in healthy Chinese subjects before and after the change of production site;
3. To observe the changes in serum total calcium (albumin corrected) concentration after a single subcutaneous injection of 100 μg of recombinant human parathyroid hormone (1-84) for injection in healthy Chinese subjects before and after the change of production site.