Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)

Phase 1

Completed

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

• Registration Number: NCT03648333
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-02
• Study Completion: 2014-06
• Status Verified: 2018-08
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-24
• Last Update Submitted: 2018-08-24
• Study First Posted: 2018-08-27
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

• Years 20-45
• Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
• Volunteer for the study and sign to ICF

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 28 days prior to study medication
• Subject with 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
• 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 60 days, component blood donation within 20 days
• Subjects receiving blood transfusion within 30 days prior to study medication dosing
• Participation in any clinical investigation within 60 days prior to study medication dosing
• Continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol (alcohol>30 g/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 28 days prior to study medication dosing
• Continued serum potassium concentration abnormal status (on baseline visit, < 3.5 mEq/L or > 5.5 mEq/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 10 mL/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<60 mL/min/1.73m2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cmax (maximum concentration)	0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
AUC(area under curve)	0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour