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Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet

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ClinicalTrials.gov Identifier: NCT01735890
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : September 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The objectives of this study are:

  • To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
  • To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers
Study Start Date : September 2012
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CJ Amlodipine/Valsartan 10/160mg Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg
single dose
Active Comparator: Novartis Exforge 10/160mg Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg
single dose


Outcome Measures

Primary Outcome Measures :
  1. pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast)) [ Time Frame: Up to 144 hours ]

Secondary Outcome Measures :
  1. AUCinf, Tmax, T1/2, CL/F [ Time Frame: up to 144 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Years 20-45
  • 18 ≤ BMI < 27kg/m²
  • volunteer

Exclusion Criteria:

  • Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
  • Subject with symptoms of acute disease within 28days prior to study medication dosing
  • Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines
  • Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing
  • Subject with known for hypersensitivity reaction to amlodipine and valsartan
  • 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. eGFR< 50mL/min ⅳ. continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L)
  • Positive test results for HBs Ab, HCV Ab, Syphilis regain test
  • Drug abuse or continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol(alcohol>30g/day)
  • Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
  • Clinically significant hypotension(SBP < 100mmHg, DBP ≤65mmHg) or hypertension(SBP 100mmHg, DBP < 65mmHg) when screening period
  • Participation in any clinical investigation within 60days prior to study medication dosing
  • Subjects with whole blood donation within 60days, component blood donation within 20days and blood transfusion within 30days prior to study medication dosing
  • 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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01735890     History of Changes
Other Study ID Numbers: CJ_AMV_102
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: November 2012

Keywords provided by CJ HealthCare Corporation:
Safety
Pharmacokinetics

Additional relevant MeSH terms:
Lactitol
Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Cathartics
Gastrointestinal Agents