Study to Compare the Safety and Pharmacokinetics of CKD-397

A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects

Inclusion criteria

• More than 19 years in Healthy male volunteer
• Body weight ≥ 55kg and in the range of calculated BMI 17.5 to 30.5kg/m2
• Subject who signed on an informed consent form willingly

Exclusion criteria

• Clinically significant disease with hematological, nephrological, respiratory, gastrointestinal, urogenital, cardiovascular, psychiatric, neurologic system and allergic disease (except for non-symptom seasonal allergy)
• Gastrointestinal disease(esophageal achalasia, esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for appendectomy or herniotomy)
• Aspartate aminotransferase, Alanine aminotransferase > 2 X upper limit of normal range or eGFR which is calculated by MDRD(Modification of diet in renal disease) < 60mL/min/1.73m2
• Continuously taking excessive alcohol(>210g/week) within 6 months before screening
• Have received any other investigational drug within 3 months prior to the first dosing
• Sitting systolic blood pressure ≤ 100mmHg or ≥ 150mmHg, sitting diastolic blood pressure ≤ 60mmHg or ≥ 100mmHg
• Subject with orthostatic hypotension
• The history of drug abuse or drug abuse showed a positive for urine drug test
• Subject who takes inducers or inhibitors of drug metabolizing enzyme within 30 days
• Cigarette ≥ 20 cigarettes a day for recent 3 months and Subject who cannot stop smoking during clinical trial participation
• Subject who takes ethical drug or herbal medicine within 2 weeks or over-the-counter drug or vitamins within 1 week
• Whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing
• Subject who can increase risk due to clinical test and administration of drugs or has severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
• Subject with taking any forms of organic nitrate periodically and/or intermittently.
• Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.
• Subject with serious history of hypersensitivity to investigational product (including Tadalafil and Tamsulosin) and other medicine (aspirin, antibiotics and so on)
• Subject who lost sight of one eye by non-arteritic anterior ischemic optic neuropathy (NAION, non-arteritic anterior ischemic optic neuropathy).
• Subject with genetic problems such as galactose intolerance, fructose intolerance, lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
• Subject who planned pregnancy during clinical trial and doesn't use trustworthy contraception
• Subjects who is not able to comply with guidelines described in the protocol.
• An impossible one who participants in clinical trials by investigator's decision including laboratory test result or another reason