A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
100mg once daily on Day 1 and Day 8
200mg once daily from Day 3 to Day10.
200mg once daily on Day 1 and Day 12.
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Maximum serum concentration (Cmax) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
Number of subjects with adverse event.
Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs.
Time frame: Up to 42 days
Time of maximum serum concentration (Tmax) SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
Half-life (t1/2) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
Apparent oral clearance (CL/F) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Time frame: Up to 14 days
Apparent oral volume of distribution (Vz/F) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
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600mg once daily from Day 3 to Day13.
Time frame: Up to 14 days