Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients
NCT00572650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2012-05-02
Summary
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.
Conditions
Interventions
- DRUG
-
vildagliptin
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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
NOVARTIS · Novartis investigator site
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2007-11-30
- Completion
- 2007-11-30
Countries
- Germany
Study Locations
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