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Trial record 59 of 99 for:    AMLODIPINE AND VALSARTAN

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)

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ClinicalTrials.gov Identifier: NCT03648333
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

Brief Summary:
To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults

Condition or disease Intervention/treatment Phase
Healthy Male Subjects Drug: Exforge tab. 10/160mg Drug: Lodivixx tab. 5/160mg Phase 1

Detailed Description:
The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
Actual Study Start Date : December 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lodivixx tab. 5/160mg
S-amlodipine nicotinate (5mg as S-amlodipine), valsartan 160mg
Drug: Lodivixx tab. 5/160mg
Other Names:
  • S-amlodipine nicotinate
  • valsartan

Active Comparator: Exforge tab. 10/160mg
amlodipine besylate (10mg as amlodipine), valsartan 160mg
Drug: Exforge tab. 10/160mg
Other Names:
  • amlodipine besylate
  • valsartan




Primary Outcome Measures :
  1. Cmax (maximum concentration) [ Time Frame: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour ]
  2. AUC(area under curve) [ Time Frame: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour ]


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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:

  • Years 20-45
  • Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
  • Volunteer for the study and sign to ICF

Exclusion Criteria:

  • Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
  • Subject with symptoms of acute disease within 28 days prior to study medication
  • Subject with history which affect on the absorption, distribution, metabolism or excretion of drug
  • Subject with clinically significant active chronic disease
  • Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. renal failure with Creatinine clearance < 50mL/min
  • Clinically significant hypotension when screening period (SBP < 100mmHg, DBP < 60mmHg)
  • Positive test results for HBs Ab, HCV Ab, Syphilis regain test
  • Use of any prescription medication within 14 days prior to study medication
  • Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
  • Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
  • Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives
  • Subject who is not able to taking the institutional standard meal
  • Subjects with whole blood donation within 60 days, component blood donation within 20 days
  • Subjects receiving blood transfusion within 30 days prior to study medication dosing
  • Participation in any clinical investigation within 60 days prior to study medication dosing
  • Continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol (alcohol>30 g/day)
  • Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
  • Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28 days prior to study medication dosing
  • Continued serum potassium concentration abnormal status (on baseline visit, < 3.5 mEq/L or > 5.5 mEq/L)
  • Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
  • Severe renal insufficient subjects (creatinine clearance : less than 10 mL/min)
  • Severe hepatic insufficient subjects,billiary cirrhosis, biliary obstruction and cholestasis patient
  • Combination with aliskiren in Diabetic patient or moderate to severe renal insufficient subjects (glomerular filtration rate<60 mL/min/1.73m2)

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): NCT03648333


Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
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Study Chair: KyoungSook Kim, PhD Metro Hospital

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Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03648333     History of Changes
Other Study ID Numbers: HL-LDV-103
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Keywords provided by Hanlim Pharm. Co., Ltd.:
amlodipine
valsartan
hypertension
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Niacin
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances