Benign Prostate Hypertrophy(BPH)
Conditions
Brief summary
A Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846
Detailed description
A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects
Interventions
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy man aged between 19 to 55 at screening 2. Weight ≥ 55kg 3. Body mass index (BMI) of 18.5 to 27.0kg/m2 4. 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 5. 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
1. Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder 2. 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 3. Those with eye diseases including genetic degenerative retinal diseases, including retinitis pigmentosa 4. Those with a past history of erection lasting more than 4 hours and priapism while taking PDE5 inhibitors such as tadalafil 5. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption 6. Persons with a history of clinically significant hypersensitivity to drugs or additives, including ingredients of clinical investigational drugs 7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8. 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 9. Those who has a drug abuse history within one year or positive reaction on urine drug screening test. 10. 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 11. People who need to take nitrate preparations or nitric oxide donors etc. regularly or intermittently during the clinical trial period 12. Those who continuously smoke excessively or consume caffeine or alcohol 13. A person who consumed food containing grapefruit within 7 days before the first administration of the investigational drug 14. 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 15. Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days 16. Those who have received blood transfusion in 30 days 17. Those who are deemed insufficient to participate in clinical study by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of D091 | Pre-dose, Post-dose Day1~Day34 (During the administration period) | Concentration of During the administration period |
| Plasma Concentration of CKD-846 | Pre-dose, Post-dose Day1~Day91 (During the administration period) | Concentration of During the administration period |
Countries
South Korea
Outcome results
None listed