Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

Inclusion criteria

• Healthy male volunteer in the age of 19-45
• Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
• Subject without a hereditary problems, chronic disease and morbid symptom
• Subject who sign on an informed consent form willingly

Exclusion criteria

• Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
• Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
• Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
• Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
• Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
• Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
• Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
• The history of drug abuse or drug abuse showed a positive for urine drug test
• Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month
• Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
• Taking drugs have received any other investigational drug within 3 months prior to the first dosing
• Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month
• Continuously taking excessive alcohol (> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge
• Cigarette > 10 cigarettes a day on average for recent 3 months
• Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
• An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason