دورية أكاديمية
Population pharmacokinetic modeling and noncompartmental analysis demonstrated bioequivalence between metformin component of metformin/vildagliptin fixed-dose combination products and metformin immediate-release tablet sourced from various countries.
| العنوان: | Population pharmacokinetic modeling and noncompartmental analysis demonstrated bioequivalence between metformin component of metformin/vildagliptin fixed-dose combination products and metformin immediate-release tablet sourced from various countries. |
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| المؤلفون: | Chitnis SD; Novartis Institutes for BioMedical Research, Cambridge, MA, USA., Han Y; Novartis Institutes for BioMedical Research, Shanghai, China., Yamaguchi M; Novartis Pharma K.K., Tokyo, Japan., Mita S; Novartis Pharma K.K., Tokyo, Japan., Zhao R; Novartis Institutes for BioMedical Research, Shanghai, China., Sunkara G; Novartis Institutes for BioMedical Research, East Hanover, NJ, USA., Kulmatycki K; Novartis Institutes for BioMedical Research, Cambridge, MA, USA. |
| المصدر: | Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2016 Jan; Vol. 5 (1), pp. 40-51. Date of Electronic Publication: 2015 May 15. |
| نوع المنشور: | Comparative Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2160-7648 (Electronic) Linking ISSN: 2160763X NLM ISO Abbreviation: Clin Pharmacol Drug Dev Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2013- : Hoboken, NJ : Wiley Original Publication: Thousand Oaks, Calif. : Sage Publications, c2012- |
| مواضيع طبية MeSH: | Models, Biological*, Hypoglycemic Agents/*administration & dosage , Metformin/*administration & dosage, Adamantane/administration & dosage ; Adamantane/analogs & derivatives ; Adolescent ; Adult ; Drug Combinations ; Female ; Humans ; Hypoglycemic Agents/pharmacokinetics ; Male ; Metformin/pharmacokinetics ; Middle Aged ; Nitriles/administration & dosage ; Pyrrolidines/administration & dosage ; Randomized Controlled Trials as Topic ; Retrospective Studies ; Tablets ; Therapeutic Equivalency ; Vildagliptin ; Young Adult |
| مستخلص: | Metformin is the first-line pharmacotherapy choice for treating type-2 diabetes mellitus, alone or in combination with other antidiabetic drugs. During the development of immediate-release (IR) metformin containing novel fixed-dose combination (FDC) products, several health-authorities require sponsors to demonstrate bioequivalence between FDC products and the country-sourced metformin for market approval. Eight bioequivalence studies that compared metformin/vildagliptin FDC product (test) to metformin IR tablet sourced from various countries (reference) were conducted. A population pharmacokinetic (PPK) analysis of pooled metformin concentration-time data was performed to evaluate whether country-sourced metformin is a significant covariate. The PPK analysis demonstrated that there was no clinically relevant effect of metformin source or race/ethnicity on metformin pharmacokinetics. Also, noncompartmental analysis conducted showed that 90%CI of geometric mean ratios of test to reference metformin formulations, calculated for maximum-concentration and exposure parameters, were within the 80%-125% criteria, indicating comparable metformin exposure regardless of the country-sourced metformin IR formulation. These results are consistent with the biopharmaceutics properties of metformin and provide scientific evidence that after assessing in vitro dissolution of novel FDC formulation, additional bioequivalence studies with multiple countries' reference products may not be required once bioequivalence is established with 1 country-sourced IR metformin formulation. (© 2015, The American College of Clinical Pharmacology.) |
| فهرسة مساهمة: | Keywords: bioequivalence; fixed‐dose combination products; metformin; population pharmacokinetics |
| المشرفين على المادة: | 0 (Drug Combinations) 0 (Hypoglycemic Agents) 0 (Nitriles) 0 (Pyrrolidines) 0 (Tablets) 9100L32L2N (Metformin) I6B4B2U96P (Vildagliptin) PJY633525U (Adamantane) |
| تواريخ الأحداث: | Date Created: 20160428 Date Completed: 20180123 Latest Revision: 20181202 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1002/cpdd.191 |
| PMID: | 27119577 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2160-7648 |
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| DOI: | 10.1002/cpdd.191 |