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Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

Information source: Elixir Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: placebo for gemfibrozil (Drug); gemfibrozil (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Elixir Pharmaceuticals

Official(s) and/or principal investigator(s):
Erin Nulf, RN, BSN, Study Director, Affiliation: Quintiles Phase I Services

Summary

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

Clinical Details

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

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

Primary outcome:

pharmacokinetics of mitiglinide

pharmacodynamics of mitiglinide

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: November 2007
Last updated: February 16, 2009

Page last updated: August 23, 2015

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