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

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ClinicalTrials.gov Identifier: NCT01823913
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Kyungsoo Park, Severance Hospital

Study Description
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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 valsartan (reference formulation) for single dose in healthy volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: Test formulation Drug: Reference formulation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Test and reference formulations
Test formulation and reference formulation given orally 14 days apart in a fasted state
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823913


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kyungsoo Park, Associate Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01823913     History of Changes
Other Study ID Numbers: G-0081
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Kyungsoo Park, Severance Hospital:
Pharmacokinetics