Drugs in R&D · 2025
A Bioequivalence Study of Recombinant Human Follicle-Stimulating Hormone Injection Versus Recombinant Human Follitropin For Injection in Healthy Chinese Adult Women.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Zhang Jigang, Zhang Mingjian, Xue Wenyuan, Zha Yixin, Jin Shujing, Luo Tianhong, Ding Ying, Gao Weiwei, Ding Xueying, Zhu Xiaoyan
Аннотация
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.
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.