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Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin

Primary Purpose

Hyperlipidemia, Diabetes

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin
Rosuvastatin
Metformin and Rosuvastatin
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 19~55 years healthy male
  • BMI measurement 19.0kg/m^2~ 28.0kg/m^2
  • Signed informed consent form from to participate voluntarily and to comply with the trial requirements.

Exclusion Criteria:

  • History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
  • SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • History of drug abuse
  • A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
  • Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
  • Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
  • Glomerular filtration rate<60mL/min
  • Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .

Sites / Locations

  • Samsung Medical Center(SMC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Metformin

Rosuvastatin

Co-administration

Arm Description

Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration

Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin

Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin

Outcomes

Primary Outcome Measures

Cmax,ss, AUCτ

Secondary Outcome Measures

Tmax,ss
t1/2
Cmin,ss
CL/Fss
Vd/Fss

Full Information

First Posted
July 4, 2014
Last Updated
March 28, 2018
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02186483
Brief Title
Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin
Official Title
An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.
Detailed Description
Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
Arm Title
Co-administration
Arm Type
Experimental
Arm Description
Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucodown OR SR tablet
Intervention Description
Metformin,1000mg, once daily
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor tablet
Intervention Description
Rosuvastatin, 20 mg, once daily
Intervention Type
Drug
Intervention Name(s)
Metformin and Rosuvastatin
Other Intervention Name(s)
Glucodown OR SR tablet and Crestor tablet
Intervention Description
Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily
Primary Outcome Measure Information:
Title
Cmax,ss, AUCτ
Time Frame
32h
Secondary Outcome Measure Information:
Title
Tmax,ss
Time Frame
32h
Title
t1/2
Time Frame
32h
Title
Cmin,ss
Time Frame
32h
Title
CL/Fss
Time Frame
32h
Title
Vd/Fss
Time Frame
32h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 19~55 years healthy male BMI measurement 19.0kg/m^2~ 28.0kg/m^2 Signed informed consent form from to participate voluntarily and to comply with the trial requirements. Exclusion Criteria: History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.) SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. History of drug abuse A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics) Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study. Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin) Glomerular filtration rate<60mL/min Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-ryul Kim, MD, Ph.D
Organizational Affiliation
Samsung Medical Center(SMC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center(SMC)
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin

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