Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: Exforge tab. 10/160mg; Drug: Lodivixx tab. 5/160mg

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyung Gi
    • Anyang, Kyung Gi, Korea, Republic of, 430-720
      • Metro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exforge tab. 10/160mg; amlodipine besylate (10mg as amlodipine); valsartan 160mg	Drug: Exforge tab. 10/160mg; Other Names: - amlodipine besylate; - valsartan
Experimental: Lodivixx tab. 5/160mg; S-amlodipine nicotinate (5mg as S-amlodipine); valsartan 160mg	Drug: Lodivixx tab. 5/160mg; Other Names: - valsartan; - S-amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum concentration)	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)
AUC(area under curve)	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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.
• Investigators: Study Chair: KyoungSook Kim, PhD, Metro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: March 25, 2013
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
• Other Study ID Numbers: HL-LDV-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No