Scholarlink

Background and Objective <p>This study aimed to evaluate the bioequivalence of a novel prefilled recombinant human follicle-stimulating hormone (rh-FSH) injection (GenSci008) compared with the existing rh-FSH for injection (Jinfollin<sup>®</sup>) in healthy Chinese adult women.</p> Methods <p>This open-label, randomized, single-center, two-period, two-sequence crossover study involved 24 healthy female volunteers who received single subcutaneous doses of both formulations, separated by a 10-day washout period. Participants underwent pituitary down-regulation using Diphereline<sup>®</sup> to minimize endogenous FSH levels. Pharmacokinetic parameters, including peak concentration (<i>C</i><sub>max</sub>), area under the drug–time curve from 0 to t (AUC<sub>0-t</sub>), and AUC from 0 to infinity (AUC<sub>0-∞</sub>) were measured, and bioequivalence was assessed based on the 90% confidence intervals (CIs) falling within the 80.00–125.00% range. Safety and immunogenicity were also evaluated.</p> Results <p>The geometric mean ratios (GMRs) and 90% CIs for baseline-corrected AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>, and <i>C</i><sub>max</sub> of the test formulation relative to the reference formulation were 99.99% (93.57–106.86), 102.70% (93.31–113.03), and 93.41% (87.77–99.41), respectively; all within the predefined bioequivalence range. Safety profiles were similar between the two formulations, with no suspected unexpected serious adverse reaction (SUSAR) identified.</p> Conclusion <p>The novel prefilled rh-FSH injection (GenSci008) is bioequivalent to the reference formulation (Jinfollin<sup>®</sup>), offering a user-friendly and precise alternative for subcutaneous administration in the treatment of infertility.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

A Bioequivalence Study of Recombinant Human Follicle-Stimulating Hormone Injection Versus Recombinant Human Follitropin For Injection in Healthy Chinese Adult Women

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年7月12日

查看全文
  • Jigang Zhang,
  • Mingjian Zhang,
  • Wenyuan Xue,
  • Yixin Zha,
  • Shujing Jin,
  • Tianhong Luo,
  • Ying Ding,
  • Weiwei Gao,
  • Xueying Ding,
  • Xiaoyan Zhu

摘要

Background and Objective

This study aimed to evaluate the bioequivalence of a novel prefilled recombinant human follicle-stimulating hormone (rh-FSH) injection (GenSci008) compared with the existing rh-FSH for injection (Jinfollin®) in healthy Chinese adult women.

Methods

This open-label, randomized, single-center, two-period, two-sequence crossover study involved 24 healthy female volunteers who received single subcutaneous doses of both formulations, separated by a 10-day washout period. Participants underwent pituitary down-regulation using Diphereline® to minimize endogenous FSH levels. Pharmacokinetic parameters, including peak concentration (Cmax), area under the drug–time curve from 0 to t (AUC0-t), and AUC from 0 to infinity (AUC0-∞) were measured, and bioequivalence was assessed based on the 90% confidence intervals (CIs) falling within the 80.00–125.00% range. Safety and immunogenicity were also evaluated.

Results

The geometric mean ratios (GMRs) and 90% CIs for baseline-corrected AUC0-t, AUC0-∞, and Cmax of the test formulation relative to the reference formulation were 99.99% (93.57–106.86), 102.70% (93.31–113.03), and 93.41% (87.77–99.41), respectively; all within the predefined bioequivalence range. Safety profiles were similar between the two formulations, with no suspected unexpected serious adverse reaction (SUSAR) identified.

Conclusion

The novel prefilled rh-FSH injection (GenSci008) is bioequivalent to the reference formulation (Jinfollin®), offering a user-friendly and precise alternative for subcutaneous administration in the treatment of infertility.