Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: Exforge tab. 10/160mg; Drug: Lodivixx tab. 5/160mg

• Registration Number: NCT01652339
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

Brief Summary

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

* PK parameter evaluation

* Safety profile evaluation

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exforge tab. 10/160mg	Exforge tab. 10/160mg	* amlodipine besylate (10mg as amlodipine) * valsartan 160mg
Lodivixx tab. 5/160mg	Lodivixx tab. 5/160mg	* S-amlodipine nicotinate (5mg as S-amlodipine) * valsartan 160mg

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of