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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 24, 2013
First Posted Date  ICMJE April 4, 2013
Last Update Posted Date April 11, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01823913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers
Official Title  ICMJE Not Provided
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Test and reference formulations
Test formulation and reference formulation given orally 14 days apart in a fasted state
Interventions:
  • Drug: Test formulation
  • Drug: Reference formulation
Publications * Kim Y, Son M, Lee D, Roh H, Son H, Chae D, Bahng MY, Park K. Pharmacokinetic comparison of 2 fixed-dose combination tablets of amlodipine and valsartan in healthy male Korean volunteers: a randomized, open-label, 2-period, single-dose, crossover study. Clin Ther. 2013 Jul;35(7):934-40. doi: 10.1016/j.clinthera.2013.05.021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2013)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823913
Other Study ID Numbers  ICMJE G-0081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyungsoo Park, Severance Hospital
Study Sponsor  ICMJE Severance Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Severance Hospital
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP