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In Sun Goak,1,2 Jin A Lee,1,3 Min Ho Jeong,4 Seol Ju Moon,1,3 Min Gul Kim1,3,5 1Department of Pharmacology, School of Medicine, Jeonbuk National University, Jeonju, Republic of Korea; 2Division of Endocrinology and Metabolism, Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Republic of Korea; 3Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Republic of Korea; 4Division of Clinical Team, Kingdom Pharmaceutical Co., Ltd, Seoul, Republic of Korea; 5Research Institute of Clinical Medicine of Jeonbuk National University, Jeonju, Republic of KoreaCorrespondence: Min Gul Kim, Department of Pharmacology, School of Medicine, Jeonbuk National University, Center for Clinical Pharmacology and Biomedical Research Institute, Jeonbuk National University Hospital, Geonji road #20, Deokjin-gu, Jeonju, 54907, Republic of Korea, Tel +82-63-250-3458, Fax +82-63-259-3483, Email mgkim@jbnu.ac.krPurpose: This study was performed to compare the pharmacokinetics of two fixed-dose combination (FDC) formulations of teneligliptin combined with modified-release metformin in healthy Korean subjects under fasting and fed conditions.Patients and Methods: The study was a single-center, open-label, single-dose, 2-way, 2-period, crossover trial. A total of 72 eligible subjects (40 subjects in the fasting state study and 32 subjects in the fed study) were enrolled in the study and were randomized to treatment. After the administration of a single FDC tablet of the investigational products, blood samples were collected at specific time intervals from 0 to 96 hours. The plasma concentrations of teneligliptin and metformin were measured by ultra performance liquid chromatography-tandem mass spectrometry (UPLC‒MS/MS). Pharmacokinetic parameters were calculated, and 90% confidence intervals (CIs) of the geometric mean ratios (test/reference) of the parameters were obtained through analysis of variance of the logarithmically transformed data.Results: The ... |