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

ConditionBenign Prostate Hypertrophy(BPH)

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

Age19-55

SponsorChong Kun Dang Pharmaceutical

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy man aged between 19 to 55 at screening

Weight ≥ 55kg

Body mass index (BMI) of 18.5 to 27.0kg/m2

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

Disqualifiers

Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder

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

Those with eye diseases including genetic degenerative retinal diseases, including retinitis pigmentosa

Those with a past history of erection lasting more than 4 hours and priapism while taking PDE5 inhibitors such as tadalafil

Trial design

Design model

Parallel

Treatments tested in this trial

CKD-846
Drug
once administration of Investigational Product
D091
Drug
once administration of Investigational Product

Treatment groups

32 Participants

are divided into 4 treatment groups

Group A: A1 (Test group)Experimental treatment 1 intervention

Group B: A2 (Test group)Experimental treatment 1 intervention

Group C: A3 (Test group)Experimental treatment 1 intervention

Group D: R (Reference group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Plasma Concentration of D091

Concentration of During the administration period

Time frame

Pre-dose, Post-dose Day1~Day34 (During the administration period)

Plasma Concentration of CKD-846

Concentration of During the administration period

Time frame

Pre-dose, Post-dose Day1~Day91 (During the administration period)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chong Kun Dang Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: