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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01735890
First received: November 25, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CJ Cheiljedang Corporation:

Primary Outcome Measures:
  • pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast)) [ Time Frame: Up to 144 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCinf, Tmax, T1/2, CL/F [ Time Frame: up to 144 hours ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01735890     History of Changes
Other Study ID Numbers: CJ_AMV_102
Study First Received: November 25, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CJ Cheiljedang Corporation:
Safety
Pharmacokinetics

Additional relevant MeSH terms:
Lactitol
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
Cathartics
Gastrointestinal Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013