Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00566865

Enrollment

Registered

2007-12-04

Start date

2007-11-30

Completion date

2007-12-31

Last updated

2009-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Interventions

DRUGplacebo for gemfibrozil

mitiglinide + placebo for gemfibrozil 600 mg bid

DRUGgemfibrozil

Mitiglinide + 600 mg gemfibrozil bid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
pharmacokinetics of mitiglinide	3 days of treatment with gemfibrozil
pharmacodynamics of mitiglinide	3 days of treatment with gemfibrozil

Secondary

Measure	Time frame
safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil	3 days of treatment with gemfibrozil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026