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Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

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ClinicalTrials.gov Identifier: NCT00566865
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Elixir Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: placebo for gemfibrozil Drug: gemfibrozil Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Gemfibrozil
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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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

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

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 Posted: December 4, 2007    Key Record Dates
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