NCT00818571

Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients

An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients

Conditions

• Renal Impairment
• Diabetes

Interventions

Type	Name	Description
DRUG	Vildagliptin	Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
DRUG	Vildagliptin	Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
DRUG	Vildagliptin	Matching healthy volunteers receiving 25 mg vildagliptin once daily.
DRUG	Vildagliptin	Matching healthy volunteers receiving 50 mg vildagliptin once daily

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-05-01
• First posted: 2009-01-07
• Last updated: 2020-12-17

Locations

1 site across 1 country: Russia