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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.
• Treatments: Metformin; Rosuvastatin Calcium

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 .