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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