Alopecia
Conditions
Brief summary
A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843
Detailed description
A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers
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 50 Years
Healthy volunteers
Yes
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 * Body Mass Index, kg/m2= Body weight(kg)/\[Height(m)2\] * 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 * AST, ALT \> 1.25 times higher than upper normal level * Total bilirubin \> 1.5 times higher than upper normal level * eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) \< 60 mL/min/1.73m2 * Positive or Reactive test result of Hepatitis B & C, HIV, RPR * Under 5 min resting condition, systolic blood pressure \>150 mmHg or \<90 mmHg, diastolic blood pressure \>100 mmHg or \<50 mmHg * 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. * Criteria: Smoke \> 10 cigarettes/day * Those who exceeding an alcohol and caffeine consumption criteria or can't stop consuming alcohol and caffeine during hospitalization period. * Criteria: Caffeine \> 5 cups/day, Alcohol \> 210 g/week * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of CKD-843-R | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | Area under the concentration-time curve from zero up to ∞ |
| AUClast of CKD-843 A, CKD-843 B | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | Area under the concentration-time curve from time zero to last |
| AUCinf of CKD-843 A, CKD-843 B | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | Area under the concentration-time curve from zero up to ∞ |
| AUC0-90days of CKD-843 A, CKD-843 B | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | Area under the concentration-time curve from time zero to 90 days |
| AUClast of CKD-843-R | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | Area under the concentration-time curve from time zero to last |
| AUC0-90days of CKD-843-R | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | Area under the concentration-time curve from time zero to 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CL/F of CKD-843-R | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | Apparent clearance |
| Tmax of CKD-843 A, CKD-843 B | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | Time to maximum plasma concentration |
| Vd/F of CKD-843-R | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | Apparent volume of distribution |
| t1/2 of CKD-843 A, CKD-843 B | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | Terminal elimination half-life |
| CL/F of CKD-843 A, CKD-843 B | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | Apparent clearance |
| Vd/F of CKD-843 A, CKD-843 B | Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours) | Apparent volume of distribution |
| Tmax of CKD-843-R | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | Time to maximum plasma concentration |
| t1/2 of CKD-843-R | Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours) | Terminal elimination half-life |
Countries
South Korea
Outcome results
None listed