Clinical trial NCT01652339: 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: 2012-07-30
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

* PK parameter evaluation
* Safety profile evaluation


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

Primary outcomes:
measure: Cmax (maximum concentration)
timeFrame: - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 points)
measure: AUC(area under curve)
timeFrame: - Valsartan evaluation : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr (14 points) - S-Amlodipine : 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168 (17 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: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
affiliation: Inje University
name: Jae Gook Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plosker GL, Robinson DM. Amlodipine/Valsartan: fixed-dose combination in hypertension. Drugs. 2008;68(3):373-81. doi: 10.2165/00003495-200868030-00008.