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
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