Status:
COMPLETED
A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Alopecia
Eligibility:
MALE
19-50 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04805606
Start Date
April 30 2021
End Date
December 24 2021
Last Update
April 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Severance Hospital
Seoul, South Korea, 120-752