Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil
NCT ID: NCT00566865
Last Updated: 2009-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2007-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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2
mitiglinide + gemfibrozil
gemfibrozil
Mitiglinide + 600 mg gemfibrozil bid
1
mitiglinide + placebo for gemfibrozil
placebo for gemfibrozil
mitiglinide + placebo for gemfibrozil 600 mg bid
Interventions
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placebo for gemfibrozil
mitiglinide + placebo for gemfibrozil 600 mg bid
gemfibrozil
Mitiglinide + 600 mg gemfibrozil bid
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 19-28 kg/m2
* no relevant food allergies
Exclusion Criteria
* any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
* clinically significant history of or current abnormality or disease of any organ system
18 Years
55 Years
ALL
Yes
Sponsors
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Elixir Pharmaceuticals
INDUSTRY
Responsible Party
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Elixir Pharmaceuticals
Principal Investigators
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Erin Nulf, RN, BSN
Role: STUDY_DIRECTOR
Quintiles Phase I Services
Other Identifiers
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EX-1510-CT-002
Identifier Type: -
Identifier Source: org_study_id
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