Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Elixir Pharmaceuticals14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

placebo for gemfibrozilDRUG

mitiglinide + placebo for gemfibrozil 600 mg bid

gemfibrozilDRUG

Mitiglinide + 600 mg gemfibrozil bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pharmacokinetics of mitiglinide

Time frame: 3 days of treatment with gemfibrozil

pharmacodynamics of mitiglinide

Time frame: 3 days of treatment with gemfibrozil

Secondary Outcomes

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

Time frame: 3 days of treatment with gemfibrozil

Data from ClinicalTrials.gov

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