Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Elixir Pharmaceuticals
• Treatments: Gemfibrozil; Mitiglinide

Criteria

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