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

NCT ID: NCT03648333

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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

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.

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lodivixx tab. 5/160mg

S-amlodipine nicotinate (5mg as S-amlodipine), valsartan 160mg

Group Type: EXPERIMENTAL

Lodivixx tab. 5/160mg

Intervention Type: DRUG

Exforge tab. 10/160mg

amlodipine besylate (10mg as amlodipine), valsartan 160mg

Group Type: ACTIVE_COMPARATOR

Exforge tab. 10/160mg

Intervention Type: DRUG

Interventions

Exforge tab. 10/160mg

Intervention Type: DRUG

Lodivixx tab. 5/160mg

Intervention Type: DRUG

Other Intervention Names

amlodipine besylate; valsartan; S-amlodipine nicotinate; valsartan

Eligibility 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KyoungSook Kim, PhD

Role: STUDY_CHAIR

Metro Hospital

Other Identifiers

HL-LDV-103

Identifier Type: -

Identifier Source: org_study_id