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Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

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: NCT02060019
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE February 11, 2014
Last Update Posted Date December 29, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2014)
Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve) [ Time Frame: 3 days ]
after steady state (Administration of Investigational Product 7day or 10days)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02060019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2014)
Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2 [ Time Frame: 3 days ]
steady state (Administration of Investigational Product)
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 Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
Official Title  ICMJE A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
Brief Summary This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
Study Arms  ICMJE
  • Experimental: exforge 10/160mg(amlodipine 10mg, valsartan160mg)
    1 tablet daily for 10days
    Intervention: Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
  • Experimental: crestor 20mg(rosuvastatin 20mg)
    1 tablet daily for 7days
    Intervention: Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
Publications * Not Provided

*   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: February 9, 2014)
57
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male volunteers in the age between 20 and 55 years old
  2. The weight range is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9
  3. Subjects with no history of any significant chronic disease
  4. Judged to be in good health on the basis of their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration
  5. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

  1. History of clinically significant allergies including drug allergies
  2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
  3. History of genetic muscular disease and family history
  4. hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
  5. AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range
  6. Creatinine clearance < 80mL/min
  7. Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
  8. Serious injury, surgery and acute illness within 4 weeks prior to drug administration
  9. History of alcohol, smoking abuse

    • alcohol > 21 units/week, 1 unit=10g=12.5mL of pure alcohol
    • smoking > 10 cigarettes/day
  10. Use of any other medication, including herbal products, within the 2 weeks before dosing
  11. Participated in a previous clinical trial within 3 months prior to drug administration
  12. Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration
  13. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
  14. Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
  15. Subjects considered as unsuitable based on medical judgement by investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 55 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 NCT02060019
Other Study ID Numbers  ICMJE CJ_EXR_101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CJ HealthCare Corporation
Study Sponsor  ICMJE CJ HealthCare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young Ran Yoon PhD Kyungpook university hostipal
PRS Account CJ HealthCare Corporation
Verification Date December 2016

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