Official Title: “A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: placebo for gemfibrozil
  • mitiglinide + placebo for gemfibrozil 600 mg bid
• Drug: gemfibrozil
  • Mitiglinide + 600 mg gemfibrozil bid

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 2
  • mitiglinide + gemfibrozil
• Placebo Comparator: 1
  • mitiglinide + placebo for gemfibrozil

Primary Measures

• pharmacokinetics of mitiglinide
  • Time Frame: 3 days of treatment with gemfibrozil
    Safety Issue?: No
• pharmacodynamics of mitiglinide
  • Time Frame: 3 days of treatment with gemfibrozil
    Safety Issue?: No

Secondary Measures

• safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil
  • Time Frame: 3 days of treatment with gemfibrozil
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Elixir Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Erin Nulf, RN, BSN Study Director Quintiles Phase I Services  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00566865

Study ID Number: EX-1510-CT-002

ClinicalTrials.gov Identifier: NCT00566865

Health Authority: United States: Food and Drug Administration