Pharmacokinetic, Pharmacodynamic, and Safety Profiles of Proline Henagliflozin in Chinese Subjects with Varying Degrees of Liver Dysfunction.
Proline henagliflozin, a novel selective inhibitor of sodium glucose cotransporter 2, is a treatment for type 2 diabetes mellitus. We designed a parallel‐group, open‐label, and multicenter study to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety profiles of henagliflozin in Chine...
| Publicado en: | Journal of Clinical Pharmacology Vol. 64; no. 8; pp. 1015 - 1023 |
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| Autores principales: | , , , , , , , , , , |
| Formato: | clinical trial pictorial research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Aug2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=178683601&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 178683601 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00912700 5WH jtl: Journal of Clinical Pharmacology issn: 00912700 maglogo: Y pubinfo: dt: Aug2024 vid: 64 iid: 8 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 178683601 176889901 178683601 178683601 10.1002/jcph.2437 178683601 ppf: 1015 ppct: 8 formats: tig: atl: Pharmacokinetic, Pharmacodynamic, and Safety Profiles of Proline Henagliflozin in Chinese Subjects with Varying Degrees of Liver Dysfunction. aug: au: Ding, Likun Yang, Lin Ren, Danjun Gao, Xiaohua Zhang, Juanli Liu, Meiyou Sun, Li Diao, Qingbo Feng, Sheng Wen, Aidong Wang, Jingwen affil: Department of Pharmacy, Xijing Hospital, the Fourth Military Medical University, Xi'an, China sug: subj: Sodium-Glucose Co-Transporter 2 Inhibitors Pharmacokinetics Sodium-Glucose Co-Transporter 2 Inhibitors Pharmacodynamics Sodium-Glucose Co-Transporter 2 Inhibitors Therapeutic Use Chinese Persons Liver Physiopathology Liver Diseases Drug Therapy Patient Safety Human Male Female Child Adult Middle Age Clinical Trials Multicenter Studies Hypoglycemic Agents Descriptive Statistics Creatinine Drug Efficacy Diabetes Mellitus, Type 2 Drug Therapy Child: 6-12 years Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: Proline henagliflozin, a novel selective inhibitor of sodium glucose cotransporter 2, is a treatment for type 2 diabetes mellitus. We designed a parallel‐group, open‐label, and multicenter study to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety profiles of henagliflozin in Chinese subjects with varying degrees of liver dysfunction. Thirty‐two subjects were enrolled and divided into four groups based on liver function (normal liver function, mild, moderate, or severe liver dysfunction). The area under the plasma concentration from time zero to infinity of henagliflozin in subjects with mild liver dysfunction, moderate liver dysfunction, and severe liver dysfunction compared with normal liver function was increased by 137%, 197%, and 204%, respectively. The maximum plasma concentration was also increased by 123%, 129%, and 139%, respectively. PK parameters of three metabolites varied to different degrees in the liver dysfunction groups than in the normal liver function group. The mean accumulative excretion amounts and fraction of dose excreted in urine expressed as a percentage were all increased with the decrease of liver function. The PD parameters were significantly higher in liver dysfunction groups than those in the normal liver function group. However, the urine creatinine (UCr) was not significantly different among the groups. No notable adverse events or adverse drug reactions were observed. Due to the higher exposures in subjects with liver dysfunction, the benefit: risk ratio should be individually assessed because the long‐term safety profile and efficacy have not been specifically studied in this population. pubtype: Academic Journal doctype: clinical trial pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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