J Clin Pharmacol
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DRUG INTERACTIONS

Evaluation of Pharmacokinetic Interactions Between Vildagliptin and Digoxin in Healthy Volunteers

Yan-Ling He, PhD, Ron Sabo, Gangadhar Sunkara, PhD, Marie-Noëlle Bizot, PhD, Gilles-Jacques Riviere, PhD, Selene Leon, PhD, Monica Ligueros-Saylan, MD, William P. Dole, MD and Dan Howard, PhD

From the Novartis Institutes for Biomedical Research, Cambridge, Massachusetts (He, Dole); Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Sabo, Sunkara, Leon, Ligueros-Saylan, Howard); and Novartis Pharma SA, Rueil-Malmaison, France (Bizot, Riviere).

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]: AUC0-24h, 0.99 [0.95-1.03]; Cmax, 0.95 [0.85-1.06]) or to digoxin (AUC0-24h, 1.02 [0.94-1.12]; Cmax, 1.08 [0.97-1.20]). In addition, no changes in tmax, t1/2, and CL/F were observed for either drug. These results indicate that no dose adjustment is necessary when vildagliptin and digoxin are coadministered.

Key Words: Type 2 diabetes • heart failure • drug interaction • vildagliptin • pharmacokinetics

Address for correspondence: Yan-Ling He, Exploratory Development-DMPK, Novartis Institutes for Biomedical Research, 400 Technology Square, Building 605, Cambridge, MA 02139-3584; e-mail: yanling.he{at}novartis.com.






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