Trials / Completed
CompletedNCT00572650
Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2007-11-01
- Completion
- 2007-11-01
- First posted
- 2007-12-13
- Last updated
- 2012-05-02
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00572650. Inclusion in this directory is not an endorsement.