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Trial record 68 of 99 for:    AMLODIPINE AND VALSARTAN

Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers

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ClinicalTrials.gov Identifier: NCT03009474
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief Summary:
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemias Drug: CJ-30060 Drug: Exforge tab 5/160mg, Crestor tab 10mg Phase 1

Detailed Description:
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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Arm Intervention/treatment
Experimental: CJ-30060
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
Drug: Exforge tab 5/160mg, Crestor tab 10mg
Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg

Active Comparator: Exforge tab 5/160mg, Crestor tab 10mg
Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
Drug: CJ-30060
Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
  2. Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
  3. Half life (t1/2) of amlodipine, valsartan, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
  4. Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
  5. Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]


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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:

  • Healthy male aged 20 to 45 years at the screening
  • Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
  • Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

Exclusion Criteria:

  • Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
  • Subject who have symptoms, result from acute disease within 28days before first administration.
  • Subject who have chronic persisting disease with clinical significance.
  • Subject who fall under the criteria below in laboratory test.

    • AST/ALT > UNL (upper normal limit) x 2
    • Total bilirubin > UNL x 1.5
    • In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault
    • CPK > UNL x 2.5
  • Subject who with low blood pressure with clinical significance at screening test.

(systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)

  • Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.

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): NCT03009474


Locations
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Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: Ji Young Park, PhD Korea University Anam Hospital

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03009474     History of Changes
Other Study ID Numbers: CJ_EXR_102
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists