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Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Shin, Dongseong Cho, Young Min Lee, SeungHwan Lim, Kyoung Soo Kim, Jeong-Ae Ahn, Ji-Yung Cho, Joo-Youn Lee, Howard Jang, In-Jin Yu, Kyung-Sang
Description	Author Affiliation: Shin D ( Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Korea.)
Abstract	BACKGROUND AND OBJECTIVE: Gemigliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes mellitus. This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability. METHODS: A randomized, open-label, multiple-dose, three-treatment, three-period, three-sequence crossover study was conducted in healthy male subjects. Twenty-seven subjects received gemigliptin (50 mg once daily), metformin (1,000 mg twice a day), or both drugs for 7 days per dosing period. Blood samples were drawn over 24 h on the seventh day of each period for pharmacokinetic and pharmacodynamic evaluations, including plasma DPP-4 activity and total/active glucagon-like peptide-1 (GLP-1) levels. Meal tolerance tests were conducted for pharmacodynamic assessment on the eighth day. Safety and tolerability were evaluated using adverse events, vital signs, ECGs, and clinical laboratory tests. RESULTS: Coadministration of gemigliptin and metformin had no significant effect on the pharmacokinetics of gemigliptin or metformin. The inhibition of DPP-4 by gemigliptin was not affected by coadministration with metformin. Co-therapy of gemigliptin and metformin showed additional effects by increasing plasma active GLP-1 concentrations and lowering serum glucose levels. The plasma glucagon level was lower in co-therapy than with metformin monotherapy. The coadministration of gemigliptin and metformin was well-tolerated without serious adverse events. CONCLUSIONS: Coadministration of gemigliptin and metformin showed beneficial anti-diabetic effects without pharmacokinetic drug-drug interactions.
File Format	HTM / HTML
ISSN	11732563
Issue Number	6
Volume Number	34
e-ISSN	11791918
Journal	Clinical Drug Investigation
Language	English
Publisher	Springer
Publisher Date	2014-06-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Hypoglycemic Agents Administration & Dosage Metformin Piperidones Pyrimidines Adult Blood Glucose Drug Effects Cross-over Studies Dipeptidyl Peptidase 4 Metabolism Dipeptidyl-peptidase Iv Inhibitors Pharmacokinetics Pharmacology Drug Interactions Glucagon Blood Glucagon-like Peptide 1 Humans Male Middle Aged Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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