Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Elixir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: placebo for gemfibrozil; Drug: gemfibrozil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00566865

EX-1510-CT-002

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

2

Experimental group

Description:

mitiglinide + gemfibrozil

Treatment:

Drug: gemfibrozil

1

Placebo Comparator group

Description:

mitiglinide + placebo for gemfibrozil

Treatment:

Drug: placebo for gemfibrozil