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Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

NCT00566865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2009-02-18

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

placebo for gemfibrozil

mitiglinide + placebo for gemfibrozil 600 mg bid

DRUG

gemfibrozil

Mitiglinide + 600 mg gemfibrozil bid

Sponsors & Collaborators

  • Elixir Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Erin Nulf, RN, BSN · Quintiles Phase I Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2007-12-31
Completion
2007-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566865 on ClinicalTrials.gov