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. |
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| 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 |
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| DOI: | 10.3389/fphar.2025.1678830 |