Status:
COMPLETED
Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Hyperlipidemia
Diabetes
Eligibility:
MALE
19-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02186483
Start Date
August 1 2014
End Date
February 1 2015
Last Update
March 29 2018
Active Locations (1)
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1
Samsung Medical Center(SMC)
Seoul, Gangnam-Gu, South Korea, 135-710