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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01652339
Other study ID # HL-LDV-101
Secondary ID
Status Completed
Phase Phase 1
First received July 19, 2012
Last updated March 25, 2013
Start date July 2012
Est. completion date December 2012

Study information

Verified date March 2013
Source Hanlim Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

- PK parameter evaluation

- Safety profile evaluation


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
Exforge tab. 10/160mg

Lodivixx tab. 5/160mg


Locations

Country Name City State
Korea, Republic of Inje University Busan Paik Hospital Busan

Sponsors (1)

Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Plosker GL, Robinson DM. Amlodipine/Valsartan: fixed-dose combination in hypertension. Drugs. 2008;68(3):373-81. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax (maximum concentration) - 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) No
Primary AUC(area under curve) - 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) No
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 Yes
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