The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 24 healthy male subjects. Subjects will receive INS068 injection on Day1 and Day8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Group A subjects were injected formulation T and formulation R of INS068 injection at Day1 and Day8.
Group B subjects were injected formulation R and formulation T of INS068 injection at Day1 and Day8.
The Qian Foshan Hospital of Shandong Province
Jinan, Shandong, China
Maximum observed serum concentration (Cmax) of INS068 injection
Time frame: from Day1 to Day5 after the first cycle(each cycle is 5 days) and from Day8 to Day12 after the second cycle(each cycle is 5 days)
Area under the plasma concentration versus time curve (AUC0-t) of INS068 injection
Time frame: from Day1 to Day5 after the first cycle(each cycle is 5 days) and from Day8 to Day12 after the second cycle(each cycle is 5 days)
Area under the plasma concentration versus time curve (AUC0-inf ) of INS068 injection
Time frame: from Day1 to Day5 after the first cycle(each cycle is 5 days) and from Day8 to Day12 after the second cycle(each cycle is 5 days)
Time to maximum observed serum concentration (Tmax) of INS068 injection
Time frame: from Day1 to Day5 after the first cycle(each cycle is 5 days) and from Day8 to Day12 after the second cycle(each cycle is 5 days)
Time to elimination half-life (T1/2) of INS068 injection
Time frame: from Day1 to Day5 after the first cycle(each cycle is 5 days) and from Day8 to Day12 after the second cycle(each cycle is 5 days)
The Clearance (CL/F) of INS068 injection
Time frame: from Day1 to Day5 after the first cycle(each cycle is 5 days) and from Day8 to Day12 after the second cycle(each cycle is 5 days)
The apparent volume of distribution (Vz/F) of INS068 injection
Time frame: from Day1 to Day5 after the first cycle(each cycle is 5 days) and from Day8 to Day12 after the second cycle(each cycle is 5 days)
Number of subjects with adverse events and the severity of adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: from Day1 to Day16 after the first dose