Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.
Seoul National University Hospital
Seoul, South Korea
AUClast of abiraterone
Area under the plasma drug concentration-time curve from 0 to last
Time frame: 72 hours
Cmax of abiraterone
The maximum or peak concentration between zero and dosing interval
Time frame: 72 hours
AUCinf of abiraterone
Area under the plasma drug concentration-time curve from 0 to infinity
Time frame: 72 hours
Tmax of abiraterone
Time of Maximum Concentration
Time frame: 72 hours
t1/2 of abiraterone
Terminal Half-life
Time frame: 72 hours
CL/F of abiraterone
An estimate of the total body clearance after oral administration
Time frame: 72 hours
Vd/F of abiraterone
Apparent volume of distribution after extravascular administration
Time frame: 72 hours
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