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

NCT01819779 | Completed Phase 1

• 1 other identifier: HL-LDV-102
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

Exforge tab. 10/160mg

ACTIVE COMPARATOR

* amlodipine besylate (10mg as amlodipine) * valsartan 160mg

Drug: Exforge tab. 10/160mg

Lodivixx tab. 5/160mg

EXPERIMENTAL

* S-amlodipine nicotinate (5mg as S-amlodipine) * valsartan 160mg

Drug: Lodivixx tab. 5/160mg

Interventions

Exforge tab. 10/160mg DRUG

Also known as: - amlodipine besylate, - valsartan

Exforge tab. 10/160mg

Lodivixx tab. 5/160mg DRUG

Also known as: - S-amlodipine, - valsartan

Lodivixx tab. 5/160mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Years 20-45
• Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
• volunteer

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Metro Hospital

Anyang, Kyung Gi, 430-720, South Korea

Location

MeSH Terms

Interventions

Amlodipine, Valsartan Drug Combination; Amlodipine; Valsartan; levamlodipine

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Study Officials

• KyoungSook Kim, PhD

  Metro Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: March 28, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

KR (1)