A single-center, randomized, open-label, two-period, crossover, fasted bioequivalence study: comparing recombinant human follicle-stimulating hormone for injection (JZB30) with Gonal-f® in healthy Chinese female participants.

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Title: A single-center, randomized, open-label, two-period, crossover, fasted bioequivalence study: comparing recombinant human follicle-stimulating hormone for injection (JZB30) with Gonal-f® in healthy Chinese female participants.
Authors: Chen Z; National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.; NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China., Yu Q; National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.; NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China., Feng S; National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.; NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China., Mo L; Chengdu Jingze Biopharmaceutical Co., Ltd., Chengdu Cross-Strait Science and Technology Industrial Development Park, Chengdu, China., Cai L; National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.; NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China., Du C; National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.; NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China., Du D; National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.; NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China., Zou Q; National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.; NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China.; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China.
Source: Frontiers in pharmacology [Front Pharmacol] 2025 Nov 10; Vol. 16, pp. 1678830. Date of Electronic Publication: 2025 Nov 10 (Print Publication: 2025).
Publication Type: Journal Article
Journal Info: Publisher: Frontiers Media] Country of Publication: Switzerland NLM ID: 101548923 Publication Model: eCollection Cited Medium: Print ISSN: 1663-9812 (Print) Linking ISSN: 16639812 NLM ISO Abbreviation: Front Pharmacol Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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ISSN:1663-9812
DOI:10.3389/fphar.2025.1678830