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

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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

Brief Summary:
This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
Study Start Date : March 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: exforge 10/160mg(amlodipine 10mg, valsartan160mg)
1 tablet daily for 10days
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
Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02060019


Locations
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Korea, Republic of
Kyungpook university hospital
Deagu, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: Young Ran Yoon PhD Kyungpook university hostipal

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT02060019     History of Changes
Other Study ID Numbers: CJ_EXR_101
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Keywords provided by CJ HealthCare Corporation:
Pharmacokinetics
Pharmacodynamics
Safety
Tolerability
Additional relevant MeSH terms:
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Amlodipine, Valsartan Drug Combination
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents