A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers
A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers
A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843
A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers
Inclusion Criteria:
Those who aged between 19 to 50 inclusion of man who concerned about androgenic alopecia.
Those who has body weight ≥ 50kg.
Those who has calculated body mass index(BMI) of 18.5 ≤ ~ < 27.0 kg/m2
Those who consent to proper contraception and do not donate sperm until 6 months after the last administration of investigational product.
Those who understanding the detailed description of this clinical trial and voluntarily decide to participate.
Exclusion Criteria:
Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Hemato-oncology disorder, Cardiovascular disorder or Psychical disorder
Those who have history of hypersensitivity to active pharmaceutical ingredient, 5α-reductase inhibitor, tocopherol.
Those who have the screening(D-28~D-2) test results written below
Those who have a drug abuse history within one year or positive reaction on urine drug screening test.
Those who received following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration and Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 30 days before the first administration of investigational product.
Those who exceeding smoke consumption criteria or can't stop smoking during hospitalization period.
Those who exceeding an alcohol and caffeine consumption criteria or can't stop consuming alcohol and caffeine during hospitalization period.
Those who took grapefruit within 7 days before the first administration of investigational product.
Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product.
Those who donated whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
Those who received transfusion within 30 days before the first administration of investigational product.
Those who are deemed inappropriate to participate in clinical trial by investigators.