Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Verified by: Elixir Pharmaceuticals, February 2009
First Received: December 3, 2007 | Last Updated: February 16, 2009 | Phase: Phase 1 | Start Date: November 2007
Overall Status: Completed | Estimated Enrollment: 14
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The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Elixir Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00566865