| Trial ID: | L2300 |
| Source ID: | NCT00566865
|
| Associated Drug: |
Placebo For Gemfibrozil
|
| Title: |
Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: placebo for gemfibrozil|DRUG: gemfibrozil
|
| Outcome Measures: |
Primary: pharmacokinetics of mitiglinide, 3 days of treatment with gemfibrozil|pharmacodynamics of mitiglinide, 3 days of treatment with gemfibrozil | Secondary: safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil, 3 days of treatment with gemfibrozil
|
| Sponsor/Collaborators: |
Sponsor: Elixir Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-11
|
| Completion Date: |
2007-12
|
| Results First Posted: |
|
| Last Update Posted: |
2009-02-18
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00566865
|