Status:
COMPLETED
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Healthy Male Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 referenc...
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 valsart...
Eligibility Criteria
Inclusion
- Years 20-45
- Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
- volunteer
Exclusion
- 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
- Severe renal insufficient subjects (creatinine clearance : less than 10mL/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\<60mL/min/1.73m2)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01819779
Start Date
March 1 2013
End Date
November 1 2013
Last Update
August 3 2018
Active Locations (1)
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1
Metro Hospital
Anyang, Kyung Gi, South Korea, 430-720