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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy Adult
Intervention	Drug: Metformin
Phase	N/A
Sponsor	Yonsei University
Responsible Party	Yonsei University
ClinicalTrials.gov Identifier	NCT01274130
First Received	January 10, 2011
Last Updated	May 10, 2012
Last verified	May 2012

Tracking Information[ + expand ][ + ]

First Received Date	January 10, 2011
Last Updated Date	May 10, 2012
Start Date	December 2010
Estimated Primary Completion Date	September 2011
Current Primary Outcome Measures	Not Provided
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers
Official Title	Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Healthy Adult
Intervention	Drug: Metformin Diavex 1000mg on Day1 and 750mg on Day2 Other Names: Diavex®
Study Arm (s)	Experimental: Ranitidine Experimental: Verapamil

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	30
Estimated Completion Date	September 2011
Estimated Primary Completion Date	September 2011
Eligibility 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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01274130
Other Study ID Numbers	4-2010-0417
Has Data Monitoring Committee	No
Information Provided By	Yonsei University
Study Sponsor	Yonsei University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	May 2012

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