Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566865
• Other study ID #: EX-1510-CT-002
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2007
• Last updated: February 16, 2009
• Start date: November 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2009
• Source: Elixir Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elixir Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetics of mitiglinide		3 days of treatment with gemfibrozil	No
Primary	pharmacodynamics of mitiglinide		3 days of treatment with gemfibrozil	No
Secondary	safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil		3 days of treatment with gemfibrozil	No