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Completed

NCT Number: NCT00566865

Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placebo for gemfibrozil

Drug

mitiglinide + placebo for gemfibrozil 600 mg bid

Gemfibrozil

Drug

Mitiglinide + 600 mg gemfibrozil bid

Primary outcomes

  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 outcomes

  1. safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil

    Time frame: 3 days of treatment with gemfibrozil

Sponsors and collaborators

Lead sponsor

Elixir Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Dec 4, 2007
Registry last updated
Feb 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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