Healthy Male Subjects Clinical Trial
Official title:
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
NCT number | NCT01819779 |
Other study ID # | HL-LDV-102 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | November 2013 |
Verified date | August 2018 |
Source | Hanlim Pharm. Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 53 |
Est. completion date | November 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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 - 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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Metro Hospital | Anyang | Kyung Gi |
Lead Sponsor | Collaborator |
---|---|
Hanlim Pharm. Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax (maximum concentration) | Valsartan : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48hr (15 points), S-amlodipine : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 120, 168hr (18 points) | ||
Primary | AUC(area under curve) | Valsartan : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48hr (15 points), S-amlodipine : 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 120, 168hr (18 points) | ||
Secondary | Number of participants with adverse events | Participants will be followed for the duration of hospital stay, an expected average of 3 days and follow-up period for maximum 6 days from the discharge |
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