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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014