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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01652339
First received: July 19, 2012
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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

  • PK parameter evaluation
  • Safety profile evaluation

Condition Intervention Phase
Healthy Male Subjects
Drug: Exforge tab. 10/160mg
Drug: Lodivixx tab. 5/160mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Cmax (maximum concentration) [ Time Frame: - 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) ] [ Designated as safety issue: No ]
  • AUC(area under curve) [ Time Frame: - 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • - S-amlodipine
  • - valsartan

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652339

Locations
Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 614-735
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
Principal Investigator: Jae Gook Shin, MD Inje University
  More Information

Publications:
Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01652339     History of Changes
Other Study ID Numbers: HL-LDV-101
Study First Received: July 19, 2012
Last Updated: March 25, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Amlodipine
Valsartan
Amlodipine, valsartan drug combination
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 15, 2014