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Evaluation of Pharmacokinetic Interactions Between Vildagliptin and Digoxin in Healthy Volunteers
Author(s) -
He YanLing,
Sabo Ron,
Sunkara Gangadhar,
Bizot MarieNoëlle,
Riviere GillesJacques,
Leon Selene,
LiguerosSaylan Monica,
Dole William P.,
Howard Dan
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270007301802
Subject(s) - vildagliptin , digoxin , crossover study , pharmacokinetics , pharmacology , medicine , dipeptidyl peptidase 4 , endocrinology , diabetes mellitus , heart failure , type 2 diabetes , placebo , alternative medicine , pathology
Vildagliptin is a novel antidiabetic agent that is an orally active, potent, and selective inhibitor of dipeptidyl peptidase IV, the enzyme responsible for degradation of the incretin hormones. This open‐label, randomized, 3‐period crossover study investigated the potential for pharmacokinetic interactions in 18 healthy subjects during coadministration of vildagliptin and digoxin. Subjects were randomized to receive each of 3 treatments: vildagliptin 100 mg qd, digoxin (0.5 mg, then 0.25 mg qd on days 2–7), and the combination vildagliptin/digoxin for 7 days. Coadministration of digoxin with vildagliptin had no effect on exposure to vildagliptin (geometric mean ratios [90% confidence interval]: AUC 0‐24h , 0.99 [0.95–1.03]; C max , 0.95 [0.85–1.06]) or to digoxin (AUC 0‐24h , 1.02 [0.94–1.12]; C max , 1.08 [0.97–1.20]). In addition, no changes in t max , t 1/2 , and CL/F were observed for either drug. These results indicate that no dose adjustment is necessary when vildagliptin and digoxin are coadministered.