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Evaluation of pharmacokinetic interactions between lobeglitazone, empagliflozin, and metformin in healthy subjects

 Heeyoung Kim  ;  Choon Ok Kim  ;  Hyeonsoo Park  ;  Min Soo Park  ;  Dasohm Kim  ;  Taegon Hong  ;  Yesong Shin  ;  Byung Hak Jin 
 Translational and Clinical Pharmacology, Vol.31(1) : 59-68, 2023-03 
Journal Title
Translational and Clinical Pharmacology
Issue Date
Diabetes Mellitus ; Drug Interactions ; Pharmacokinetics ; Thiazolidinediones
Concomitant administration of lobeglitazone, empagliflozin, and metformin is expected to enhance blood glucose-lowering effects and improve medication compliance in patients with diabetes mellitus. In this study, we investigated the pharmacokinetic (PK) interactions and safety of lobeglitazone and co-administered empagliflozin and metformin, which are approved agents used in clinical settings. Two randomized, open-label, multiple-dose, 2-treatment, 2-period, 2-sequence crossover clinical trials (parts 1 and 2) were conducted independently. In part 1, lobeglitazone monotherapy or lobeglitazone, empagliflozin, and metformin triple therapy was administered for 5 days. In part 2, empagliflozin and metformin dual therapy or the abovementioned triple therapy were administered for 5 days. Serial blood samples were collected up to 24 hours after the last dose in each period for PK evaluation. The primary PK parameters (AUCtau,ss, Cmax,ss) of treatment regimens in each study part were calculated and compared. For lobeglitazone, the geometric mean ratios (GMRs) with 90% confidence intervals (CI) for triple therapy over monotherapy were 1.08 (1.03–1.14) for Cmax,ss and 0.98 (0.90–1.07) for AUCtau,ss. For empagliflozin, the GMRs and 90% CIs for triple therapy over dual therapy were 0.87 (0.78–0.97) for Cmax,ss and 0.97 (0.93–1.00) for AUCtau,ss. For metformin, the GMRs and 90% CIs for triple therapy over dual therapy were 1.06 (0.95– 1.17) for Cmax,ss and 1.04 (0.97–1.12) for AUCtau,ss. All reported adverse events were mild. The triple therapy consisting of lobeglitazone, empagliflozin, and metformin did not show any clinically relevant drug interactions in relation to the PKs and safety of each drug substance. Trial Registration: ClinicalTrials.gov Identifier: NCT04334213. © 2023 Translational and Clinical Pharmacology.
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6. Others (기타) > Dept. of Clinical Pharmacology (임상시험센터) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Physiology (생리학교실) > 1. Journal Papers
Yonsei Authors
Kim, Choon Ok(김춘옥) ORCID logo https://orcid.org/0000-0002-2319-1108
Kim, Hee Young(김희영) ORCID logo https://orcid.org/0000-0002-2495-9115
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
Hong, Tae Gon(홍태곤) ORCID logo https://orcid.org/0000-0001-7490-0085
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