Overview

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