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The objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ Amlodipine/Valsartan 10/160mg | Experimental |
| |
| Novartis Exforge 10/160mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ Amlodipine/Valsartan 10/160mg | Drug | single dose |
| |
Inclusion Criteria:
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
Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Novartis Exforge 10/160mg |
| Drug |
single dose |
|
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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