Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients
This study has been completed.
Information provided by:
First received: December 12, 2007
Last updated: April 30, 2012
Last verified: April 2012
This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of LAF237 and Its Metabolites in Mild Renal Impaired Patients Compared to Age, Sex and Weight-matched Healthy Volunteers Following Daily Doses of 100 mg LAF237 for 14 Days|
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Pharmacokinetic measures [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability measures [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days.
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