Status:
COMPLETED
Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers
Lead Sponsor:
Severance Hospital
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsa...
Eligibility Criteria
Inclusion
- Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
Exclusion
- History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
- Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
- Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
- Use of any substance that could induce or inhibit drug metabolism enzymes
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01823913
Start Date
July 1 2012
End Date
September 1 2012
Last Update
April 11 2013
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 120-752