Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

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 valsartan (reference formulation) for single dose in healthy volunteers

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

Details

• Lead Sponsor: Severance Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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