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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation
ClinicalTrials.gov Identifier:
NCT01494727
First received: December 15, 2011
Last updated: April 29, 2012
Last verified: April 2012
  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
Drug: 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:


Further study details as provided by CJ HealthCare Corporation:

Estimated Enrollment: 48
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CJ Amlodipine/Valsartan 10/160mg Drug: CJ Amlodipine/Valsartan 10/160mg
single dose
Active Comparator: Novartis Exforge 10/160mg Drug: 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:

  • Male volunteers in the age between 20 and 45 years old
  • Body Mass Index (BMI) in the range of 19 to 27 kg/m2

Exclusion Criteria:

  • History of allergy or sensitivity to any drug, including amlodipine or valsartan
  • History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease
  • History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
  • Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg)
  • Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
  • Clinical laboratory test values are outside the accepted normal range

    • Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 1.25 times to normal range
    • Total bilirubin > 1.25 times to normal range
  • Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)
  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: NCT01494727

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
  More Information

No publications provided

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01494727     History of Changes
Other Study ID Numbers: CJ_AMV_101
Study First Received: December 15, 2011
Last Updated: April 29, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CJ HealthCare Corporation:
Safety
Pharmacokinetics

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

ClinicalTrials.gov processed this record on October 29, 2014