Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: gemfibrozil; Drug: placebo for gemfibrozil

• Registration Number: NCT00566865
• Lead Sponsor: Elixir Pharmaceuticals

Brief Summary

The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-16
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• non-smoker
• Body mass index (BMI) of 19-28 kg/m2
• no relevant food allergies

Exclusion Criteria

• any subject for whom gemfibrozil is contraindicated
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	gemfibrozil	mitiglinide + gemfibrozil
1	placebo for gemfibrozil	mitiglinide + placebo for gemfibrozil

Primary Outcome Measures

Name	Time	Method
pharmacokinetics of mitiglinide	3 days of treatment with gemfibrozil
pharmacodynamics of mitiglinide	3 days of treatment with gemfibrozil

Secondary Outcome Measures

Name	Time	Method
safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil	3 days of treatment with gemfibrozil