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) |
|
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 |
Locations[ + expand ][ + ]
Severance Hospital | Seoul, Korea, Republic of, 120-752 |
---|