Pharmacokinetics and Bioequivalence of Two Combination Metformin/Glipizide Tablets under Fasting and Fed Conditions in Chinese Healthy Subjects: A Randomized, Open-Label, Crossover Study.
Metformin/glipizide tablets are a compound formulation composed of metformin hydrochloride and glipizide. This study aimed to assess the pharmacokinetics and bioequivalence of two fixed-dose combination (FDC) tablets of metformin/glipizide (500 mg/2.5 mg) in healthy Chinese subjects. We conducted a...
| Publicado en: | Journal of Clinical Pharmacy & Therapeutics Vol. 2024; pp. 1 - 10 |
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| Autores principales: | , , , , , , , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wiley-Blackwell
4/10/2024
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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=176567323&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 176567323 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 02694727 EV4 jtl: Journal of Clinical Pharmacy & Therapeutics issn: 02694727 maglogo: Y pubinfo: dt: 4/10/2024 vid: 2024 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 176567323 176567323 176567323 10.1155/2024/9200636 176567323 ppf: 1 ppct: 9 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Pharmacokinetics and Bioequivalence of Two Combination Metformin/Glipizide Tablets under Fasting and Fed Conditions in Chinese Healthy Subjects: A Randomized, Open-Label, Crossover Study. aug: au: Lei, Yuyan Yan, Yu Huang, Lifeng Li, Canxia Liu, Wanying Shen, Qiuxia Wang, Caihong Yang, Hongying Li, Xiaohui Zhang, Wanyu Chen, Jing Su, Jiankun Xie, Yuhong Chen, Weiming Li, Chao Lu, Junli Chen, Lulu affil: Phase I Clinical Trial Laboratory, The Second Nanning People's Hospital, Nanning, China sug: subj: Metformin Pharmacokinetics Glipizide Pharmacokinetics Drug Combinations Pharmacokinetics Preprocedural Fasting Postprandial Period Chinese Persons Human Randomized Controlled Trials Random Assignment Crossover Design Male Female Adolescence Adult Blood Specimen Collection Metformin Blood Glipizide Blood Descriptive Statistics Confidence Intervals ROC Curve China Adolescent: 13-18 years Adult: 19-44 years Male Female ab: Metformin/glipizide tablets are a compound formulation composed of metformin hydrochloride and glipizide. This study aimed to assess the pharmacokinetics and bioequivalence of two fixed-dose combination (FDC) tablets of metformin/glipizide (500 mg/2.5 mg) in healthy Chinese subjects. We conducted a single-center, open-label, randomized, two-way crossover study with a total of 48 subjects enrolled (24 in each dietary group). The test or reference formulations were given to the subjects at random at a ratio of 1 : 1, with a seven-day washout period. Blood samples, collected at prearranged intervals before and up to 24 hours after dosage, were analyzed using validated LC-MS/MS technology to ascertain plasma concentrations of metformin and glipizide. Finally, 23 subjects completed the fasting and fed studies, respectively. In both studies, the 90% confidence intervals for the geometric mean ratios (test/reference) of the C m ax , AUC0-t, and AUC0-∞ were all found to fall within the acceptable range for bioequivalence (80%–125%). The exposure of metformin/glipizide FDC tablets in vivo was not significantly affected by food. No serious adverse events were observed. In conclusion, this study demonstrated that both the test and reference metformin/glipizide tablets exhibited bioequivalence and were well tolerated under both fasting and fed conditions. This trial is registered with CTR202686. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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