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Trial record 19 of 99 for:    AMLODIPINE AND VALSARTAN

Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02069821
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief Summary:
The purpose of the study is to assess the pharmacokinetic interactions between amlodipine besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: combination administration Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of Exforge® (Amlodipine Besylate/Valsartan) and Lipitor® (Atorvastatin Ca) in Healthy Male Volunteers
Study Start Date : March 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Group A
single administration : amlodipine/valsartan 10/160mg, qd, 10days(oral)
Drug: combination administration
combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)

Experimental: Group B
single administration : atorvastatin 40mg, qd, 7days(oral)
Drug: combination administration
combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)




Primary Outcome Measures :
  1. To Evaluate PK interaction of amlodipine and valsartan [ Time Frame: from pre dosing to 24hr post dose ]
    AUCss,τ, Css,max

  2. To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin [ Time Frame: from pre dosing to 24hr post dose ]
    AUCss,τ, Css,max


Secondary Outcome Measures :
  1. To Evaluate PK interaction of amlodipine and valsartan [ Time Frame: from pre dosing to 24hr post dose ]
    tss,max, CLss/F, Css,min

  2. To Evaluate PK interaction of atorvastatin and 2-OH atorvastatin [ Time Frame: from pre dosing to 24hr post dose ]
    tss,max, CLss/F, Css,min



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male volunteers in the age between 20 and 45 years old
  2. The weight is over 55kg and 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 routine laboratory data obtained prior to study drug administration
  5. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

  1. Subjects with Symptoms of acute disease within 28days prior to study medication dosing
  2. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
  3. Subjects with a history of clinically significant allergies including drug allergies or anaphylaxis to amlodipine, valsartan and/or atorvastatin
  4. Subjects with a history of myopathy
  5. Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  6. Subject with the mean blood pressure of siDBP ≥ 150 mmHg or ≤ 90 mmHg and/or siSBP ≥ 95 mmHg or ≤ 50 mmHg at the screening visit
  7. Subjects with abnormal HDL-cholesterol(<35mg/dL)
  8. Subjects with abnormal of serum potassium concentration (<3.4 mEq/L of >5.5 mEq/L in screening visit)
  9. Subjects with a history of drug abuse
  10. Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
  11. Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 14days prior to drug administration and OTC or vitamin within 7days prior to drug administration
  12. Participated in a previous clinical trial within 60 days prior to dosing
  13. Donated blood within 60 days prior to dosing
  14. Subjects with a history of alcohol abuse(over 21 units/week, 1 unit = 10 g of pure alcohol) or is difficult to stop drinking within study
  15. Subjects have ever smoked over 10 cigarette per day within 3 months prior to drug administration
  16. Subjects with a history of caffeine abuse or or is difficult to stop drinking within study
  17. Subjects with biliary obstruction
  18. Subjects with hepatic dysfunction (AST or ALT >3 times to accepted normal range)
  19. Subjects with moderate renal dysfunction (creatinine clearance (CLcr) < 30mL/min)
  20. Subjects considered as unsuitable based on medical judgement by investigators

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): NCT02069821


Locations
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Korea, Republic of
Chungnam national university hospital
Daejeon, Jung-gu, Korea, Republic of, 301-721
Sponsors and Collaborators
CJ HealthCare Corporation

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT02069821     History of Changes
Other Study ID Numbers: CJ_EXA_101
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists