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

December 15, 2011
April 29, 2012
February 2012
April 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01494727 on ClinicalTrials.gov Archive Site
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Not Provided
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Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg
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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: CJ Amlodipine/Valsartan 10/160mg
    single dose
  • Drug: Novartis Exforge 10/160mg
    single dose
  • Experimental: CJ Amlodipine/Valsartan 10/160mg
    Intervention: Drug: CJ Amlodipine/Valsartan 10/160mg
  • Active Comparator: Novartis Exforge 10/160mg
    Intervention: Drug: Novartis Exforge 10/160mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2012
April 2012   (final data collection date for primary outcome measure)

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)
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01494727
CJ_AMV_101
No
CJ HealthCare Corporation
CJ HealthCare Corporation
Not Provided
Not Provided
CJ HealthCare Corporation
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP