Status:
COMPLETED
Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01494727
Start Date
February 1 2012
End Date
April 1 2012
Last Update
May 1 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea