Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

Hanlim Pharm

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: Lodivixx tab. 5/160mg; Drug: Exforge tab. 10/160mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01652339

HL-LDV-101

Details and patient eligibility

About

To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects

• PK parameter evaluation
• Safety profile evaluation

Enrollment: 40 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Years 20-45
• Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
• volunteer

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 28days prior to study medication dosing
• Subject with known for 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 dosing
• 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 60days, component blood donation within 20days
• Subjects receiving blood transfusion within 30days prior to study medication dosing
• Participation in any clinical investigation within 60days prior to study medication dosing
• Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker (cigarette > 10 cigarettes per 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 28days prior to study medication dosing
• Continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/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

Trial design

40 participants in 2 patient groups

Exforge tab. 10/160mg

Active Comparator group

Description:

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

Treatment:

Drug: Exforge tab. 10/160mg

Lodivixx tab. 5/160mg

Experimental group

Description:

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

Treatment:

Drug: Lodivixx tab. 5/160mg