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Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566865
First Posted: December 4, 2007
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Elixir Pharmaceuticals
  Purpose
The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: placebo for gemfibrozil Drug: gemfibrozil Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Elixir Pharmaceuticals:

Primary Outcome Measures:
  • pharmacokinetics of mitiglinide [ Time Frame: 3 days of treatment with gemfibrozil ]
  • pharmacodynamics of mitiglinide [ Time Frame: 3 days of treatment with gemfibrozil ]

Secondary Outcome Measures:
  • safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil [ Time Frame: 3 days of treatment with gemfibrozil ]

Enrollment: 14
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
mitiglinide + gemfibrozil
Drug: gemfibrozil
Mitiglinide + 600 mg gemfibrozil bid
Placebo Comparator: 1
mitiglinide + placebo for gemfibrozil
Drug: placebo for gemfibrozil
mitiglinide + placebo for gemfibrozil 600 mg bid

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566865


Sponsors and Collaborators
Elixir Pharmaceuticals
Investigators
Study Director: Erin Nulf, RN, BSN Quintiles Phase I Services
  More Information

Responsible Party: Paul Martha, Chief Medial Officer, Elixir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00566865     History of Changes
Other Study ID Numbers: EX-1510-CT-002
First Submitted: December 3, 2007
First Posted: December 4, 2007
Last Update Posted: February 18, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gemfibrozil
Mitiglinide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs