Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers
Overview
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
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2012
Interventions
- Drug: Test formulation
- A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg
- Drug: Reference formulation
- A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg
Arms, Groups and Cohorts
- Experimental: Test and reference formulations
- Test formulation and reference formulation given orally 14 days apart in a fasted state
Clinical Trial Outcome Measures
Primary Measures
- Profile of Pharmacokinetics
- Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose
- Cmax, Area Under Curve(0 to the last sampling time)
Secondary Measures
- Profile of Pharmacokinetics
- Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose
- Tmax, Area Under Curve(0 to infinity), T_1/2
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Severance Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Kyungsoo Park, Associate Professor – Severance Hospital
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