Effect of glimepiride on the pharmacokinetics of teneligliptin in healthy Korean subjects.

What is known and objective: Teneligliptin is a DPP‐4 inhibitor used for the treatment of type 2 diabetes mellitus, commonly prescribed in combination with glimepiride. Teneligliptin is metabolized by CYP3A4, and glimepiride might be partly metabolized by CYP3A4. The aim of the study was to investig...

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Publicado en:Journal of Clinical Pharmacy & Therapeutics Vol. 44; no. 5; pp. 720 - 726
Autores principales: Park, Jin‐Woo, Kim, Kyoung‐Ah, Choi, Yun Jung, Yoon, Soo Hyun, Park, Ji‐Young
Formato: clinical trial research tables/charts Journal Article
Publicado: Wiley-Blackwell Oct2019
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Oct2019
      vid: 44
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/jcpt.12848
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        atl: Effect of glimepiride on the pharmacokinetics of teneligliptin in healthy Korean subjects.
      aug:
        au:
          Park, Jin‐Woo
          Kim, Kyoung‐Ah
          Choi, Yun Jung
          Yoon, Soo Hyun
          Park, Ji‐Young
        affil: Department of Clinical Pharmacology and Toxicology, Korea University College of Medicine, Korea University Anam Hospital, Seoul Korea
      sug:
        subj:
          Glimepiride Pharmacodynamics
          Dipeptidyl Peptidase 4 Inhibitors Pharmacokinetics
          Drug Interactions
          Human
          South Korea
          Clinical Trials
          Dipeptidyl Peptidase 4 Inhibitors Administration and Dosage
          Glimepiride Administration and Dosage
          Dipeptidyl Peptidase 4 Inhibitors Metabolism
          Dipeptidyl Peptidase 4 Inhibitors Blood
          Time Factors
          Descriptive Statistics
          Confidence Intervals
      ab: What is known and objective: Teneligliptin is a DPP‐4 inhibitor used for the treatment of type 2 diabetes mellitus, commonly prescribed in combination with glimepiride. Teneligliptin is metabolized by CYP3A4, and glimepiride might be partly metabolized by CYP3A4. The aim of the study was to investigate the possible effect of glimepiride on the pharmacokinetics of teneligliptin in healthy subjects. Methods: A repeated dose, open‐label, fixed‐sequence study was conducted in 26 healthy subjects. All participants were administered 20 mg teneligliptin daily for 6 days. On day 7, 4 mg glimepiride was administered together with 20 mg teneligliptin. Plasma teneligliptin concentrations were measured at a steady state, and its pharmacokinetic characteristics were compared without and with glimepiride. Results and discussion: No statistically significant difference was found in the effect of glimepiride on teneligliptin pharmacokinetics. The steady‐state Cmax,ss values of teneligliptin without and with glimepiride were 207.01 ng/mL and 202.15 ng/mL, respectively. Its AUCτ values at steady‐state without and with glimepiride were 1527.8 ng · h/mL and 1578.6 ng · h/mL, respectively. The point estimation of geometric mean ratios (GMR) and the 90% confidence interval for both Cmax,ss and AUCτ were within the equivalence range of 0.8‐1.25. The results of the present study revealed that glimepiride did not cause pharmacokinetic interaction with teneligliptin in humans. What is new and conclusion: Glimepiride did not affect the pharmacokinetic characteristics of teneligliptin in healthy subjects.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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