Status:
COMPLETED
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects
Lead Sponsor:
LG Life Sciences
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alo...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 Criteria
- 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, irbesartan, 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
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01825850
Start Date
June 1 2013
End Date
March 1 2014
Last Update
December 30 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea