Clincosm LogoSign in Get a demo

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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01274130
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
9
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ranitidine

Drug: Metformin
Diavex 1000mg on Day1 and 750mg on Day2
Other Names:
  • Diavex®

    		•
    Experimental: Verapamil

    Drug: Metformin
    Diavex 1000mg on Day1 and 750mg on Day2
    Other Names:
  • Diavex®

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 50 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Severance Hospital Seoul Korea, Republic of 120-752

      Sponsors and Collaborators

      • Yonsei University

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Yonsei University
      ClinicalTrials.gov Identifier:
      NCT01274130
      Other Study ID Numbers:
      • 4-2010-0417
      First Posted:
      Jan 11, 2011
      Last Update Posted:
      May 11, 2012
      Last Verified:
      May 1, 2012
      Additional relevant MeSH terms:
      Metformin

      Study Results

      No Results Posted as of May 11, 2012