| Trial ID: | L2462 |
| Source ID: | NCT01131091
|
| Associated Drug: |
Sk-0403
|
| Title: |
A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: SK-0403
|
| Outcome Measures: |
Primary: The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403., 72 Hours | Secondary: The secondary objective is to determine the safety and tolerability of a single 400 mg dose of SK 0403 in subjects with renal insufficiency., 72 Hours
|
| Sponsor/Collaborators: |
Sponsor: Kowa Research Institute, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose:
|
| Start Date: |
2010-05
|
| Completion Date: |
2010-11
|
| Results First Posted: |
|
| Last Update Posted: |
2011-02-10
|
| Locations: |
Orlando, Florida, United States|Minneapolis, Minnesota, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01131091
|
