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A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group - A1(Part 1) | Experimental | CKD-843 A 45mg |
|
| Group - A2(Part 2) | Experimental | CKD-843 A 45mg |
|
| Group - B1(Part 1) | Experimental | CKD-843 A 55mg |
|
| Group - B2(Part 2) | Experimental | CKD-843 A 55mg |
|
| Group - R(Part 1) | Active Comparator | CKD-843-R |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-843 A 45mg(Multiple dose) | Drug | 1 Injection/3 Month, 3 times Injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0 to Day 271 | Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271 | Pre-dose(Day 1 - 0 hour), Day 1 - 4 hours, Day 2, Day 8, Day 15, Day 30, Day 46, Day 61, Day 91, Day 91 - 4 hours, Day 92, Day 98, Day 105, Day 121, Day 136, Day 151, Day 181, Day 181 4 hours, Day 182, Day 188, Day 195, Day 211, Day 226, Day 241, Day 271 |
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Inclusion Criteria:
Those who aged between 19 to 50
(Part 1) Those who are diagnosed to androgenic alopecia and meet criteria BASP grade
(Part 1) Those who consent to the condition write below
(Part 2) Those who are healthy male (Regardless of alopecia)
Those who has body weight ≥ 55kg
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
(Part 1) Those who meets the conditions write below
Those who take dutasteride or finasteride within 6 month before the first administration of investigational product
Those who has hypersensitivity to dutasteride or other 5-alpha reductase related inhibitors.
Those who have the screening(D-28~D-2) test results write below
Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
Those who receive 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 & alcohol consumption criteria.
Those who take grapefruit within 7 days before the first administration of investigational product.
Those who receive investigational product by participating in other clinical trial within 180 days before the first administration of investigational product.
Those who donate whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
Those who receive transfusion within 30 days before the first administration of investigational product.
Those who are deemed inappropriate to participate in clinical trial by investigators.
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| Name | Affiliation | Role |
|---|---|---|
| Minsoo Park, M.D., Ph.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| CKD-843 A 45mg |
| Drug |
Single Injection |
|
| CKD-843 A 55mg(Multiple dose) | Drug | 1 Injection/3 Month, 3 times Injections |
|
| CKD-843 A 55mg | Drug | Single Injection |
|
| CKD-843-R | Drug | 0.5mg/day, 9 Month |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |