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
1 other identifier
interventional
48
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Feb 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 19, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 1, 2012
April 1, 2012
2 months
December 15, 2011
April 29, 2012
Conditions
Keywords
Study Arms (2)
CJ Amlodipine/Valsartan 10/160mg
EXPERIMENTALNovartis Exforge 10/160mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male volunteers in the age between 20 and 45 years old
- Body Mass Index (BMI) in the range of 19 to 27 kg/m2
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 19, 2011
Study Start
February 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 1, 2012
Record last verified: 2012-04