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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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  Data: 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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  Data: <searchLink fieldCode="AU" term="%22Chen+Z%22">Chen Z</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Yu+Q%22">Yu Q</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Feng+S%22">Feng S</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Mo+L%22">Mo L</searchLink>; Chengdu Jingze Biopharmaceutical Co., Ltd., Chengdu Cross-Strait Science and Technology Industrial Development Park, Chengdu, China.<br /><searchLink fieldCode="AU" term="%22Cai+L%22">Cai L</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Du+C%22">Du C</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Du+D%22">Du D</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Zou+Q%22">Zou Q</searchLink>; 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.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Frontiers+Media]%22">Frontiers Media] </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101548923 <i>Publication Model: </i>eCollection <i>Cited Medium: </i>Print <i>ISSN: </i>1663-9812 (Print) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2216639812%22">16639812 </searchLink><i>NLM ISO Abbreviation: </i>Front Pharmacol <i>Subsets: </i>PubMed not MEDLINE
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              Text: 2025 Nov 10
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