A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
- Registration Number
- NCT06014853
- Lead Sponsor
- Bukwang Pharmaceutical
- Brief Summary
Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study
- Detailed Description
To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
- healthy adult male volunteers between 19 to 50 years of age at screening visit.
- Body mass index (BMI) between 19.0 to 30.0 kg/m2
- The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent
- The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.)
Exclusion Criteria
- Clinically significant abnormal physical examination, vital signs or ECG
- The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction.
- The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- The subjects who have a history of drug abuse or positive with urine drug screening test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 4 Zytiga Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg Group 3 SOL-804-F Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg Group 2 Zytiga Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg Group 1 Zytiga Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg Group 3 Zytiga Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg Group 4 SOL-804-F Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg Group 2 SOL-804-F Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg Group 1 SOL-804-F Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg
- Primary Outcome Measures
Name Time Method Cmax of abiraterone 72 hours The maximum or peak concentration between zero and dosing interval
AUClast of abiraterone 72 hours Area under the plasma drug concentration-time curve from 0 to last
- Secondary Outcome Measures
Name Time Method Tmax of abiraterone 72 hours Time of Maximum Concentration
t1/2 of abiraterone 72 hours Terminal Half-life
AUCinf of abiraterone 72 hours Area under the plasma drug concentration-time curve from 0 to infinity
Vd/F of abiraterone 72 hours Apparent volume of distribution after extravascular administration
CL/F of abiraterone 72 hours An estimate of the total body clearance after oral administration
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of