A Clinical Trial to Compare and Evaluate Evaluate the Pharmacokinetics and Safety of CKD-846

Chong Kun Dang

Status and phase: Not yet enrolling; Phase 1

Conditions: Benign Prostate Hypertrophy(BPH)

Treatments: Drug: D091; Drug: CKD-846

Study type: Interventional

Funder types: Industry

Identifiers

NCT07404735

A133_02PK2504

Details and patient eligibility

About

A Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846

Full description

A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects

Enrollment: 32 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

A1 (Test group)

Experimental group

Description:

CKD-846, Single dose

Treatment:

Drug: CKD-846

A2 (Test group)

Experimental group

Description:

CKD-846, Single dose

Treatment:

Drug: CKD-846

A3 (Test group)

Experimental group

Description:

CKD-846, Single dose

Treatment:

Drug: CKD-846

R (Reference group)

Experimental group

Description:

D091, Multi dose

Treatment:

Drug: D091