Status:
COMPLETED
Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin
Lead Sponsor:
LG Life Sciences
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects
Eligibility Criteria
Inclusion
- Age between 20 to 45, healthy male subjects (at screening)
- BMI between 18 - 27 kg/m2 (at screening)
- Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
- FPG 70-125mg/dL glucose level (at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the
Exclusion
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)
- Subject who already admitted in other investigator product in 80 days
- Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01823133
Start Date
April 1 2013
End Date
August 1 2013
Last Update
August 28 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea