A Clinical Trial to Compare and Evaluate Evaluate the Pharmacokinetics and Safety of CKD-846

A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects

Inclusion criteria

• Healthy man aged between 19 to 55 at screening
• Weight ≥ 55kg
• Body mass index (BMI) of 18.5 to 27.0kg/m2
• Those who agree to contraception from the first Investigational Product(IP) dosing day till 6 months after the last dosing day and decide not to provide sperm during the participation of clinical trial
• Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial

Exclusion criteria

• Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder
• Those who have a history of clinically significant cardiovascular diseases such as myocardial infarction, angina pectoris, ventricular arrhythmia, heart failure, left ventricular outflow tract stenosis, stroke, and transient ischemic attack within 2 years prior to the first administration of the investigational drug
• Those with eye diseases including genetic degenerative retinal diseases, including retinitis pigmentosa
• Those with a past history of erection lasting more than 4 hours and priapism while taking PDE5 inhibitors such as tadalafil
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption
• Persons with a history of clinically significant hypersensitivity to drugs or additives, including ingredients of clinical investigational drugs
• Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• A person who is judged to be unsuitable as a test subject in a screening test conducted within 28 days before administration of the investigational drug
• Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
• Those who has taken over-the-counter or prescription drugs, excluding topical agents without significant systemic absorption, within a specified period of time and the administered drug is judged to have an effect on this test or may affect the safety of the subject
• People who need to take nitrate preparations or nitric oxide donors etc. regularly or intermittently during the clinical trial period
• Those who continuously smoke excessively or consume caffeine or alcohol
• A person who consumed food containing grapefruit within 7 days before the first administration of the investigational drug
• Persons who participated in another clinical trial (including bioequivalence test) and received an investigational drug within 180days prior to the date of first administration of the investigational drug
• Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days
• Those who have received blood transfusion in 30 days
• Those who are deemed insufficient to participate in clinical study by investigators