Clinical trial NCT01819779: Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)
Official title: Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cmax (maximum concentration)
timeFrame: 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)
measure: AUC(area under curve)
timeFrame: 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 outcomes:
measure: Number of participants with adverse events
timeFrame: 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
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Metro Hospital
state: Kyung Gi
Study officials:
affiliation: Metro Hospital
name: KyoungSook Kim, PhD
role: STUDY_CHAIR
References: