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Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers

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

Condition(s) targeted: Healthy Adult

Intervention: Metformin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Yonsei University

Summary

This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The investigators will apply ranitidine and verapamil to the drug interaction study of metformin.

Clinical Details

Official title: Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male volunteers aged 20 to 50 years at screening

- Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body

weight : Ideal body weight = (height cm - 100) x 0. 9

- Subjects who provided written, voluntary informed consent to participate in this

clinical trial and to comply the directions including contraception after being fully informed of and understand this trial Exclusion Criteria:

- Subjects who have the clinically significant diseases or history in liver, kidney,

nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.

- Subjects who have participated in other clinical trial within 1 month prior to the

first day of drug administration

- Subjects who are inappropriate in the judgement of the investigator due to the

reasons including clinical laboratory test results

Locations and Contacts

Severance Hospital, Seoul 120-752, Korea, Republic of
Additional Information

Starting date: December 2010
Last updated: May 10, 2012

Page last updated: August 23, 2015

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