Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A

Inclusion criteria

• Healthy male volunteer in the age between 19 and 45 years old.
• Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
• Subjects without a hereditary problems and chronic disease.
• Subjects whose clinical laboratory test values are inside the accepted normal range.
• Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion criteria

• Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
• History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
• History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
• Subjects with galactose intolerance.
• SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 BPM.
• AST or ALT > 2*ULN, total bilirubin > 2*ULN
• Serum Creatinine > ULN
• Previous history or present of drug abuse.
• Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
• Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
• Subjects treated IP within 2 months prior to the first dosing.
• Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
• Alcohol > 21 units/week or cannot stop drinking.
• Cigarette > 10 cigarettes/day.
• Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
• Not eligible to participate for the study at the discretion of investigator.