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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01494727
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

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 Drug: Novartis Exforge 10/160mg Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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




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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494727


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

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01494727     History of Changes
Other Study ID Numbers: CJ_AMV_101
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by CJ HealthCare Corporation:
Safety
Pharmacokinetics

Additional relevant MeSH terms:
Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Lactitol
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