This trial is a Single-center, non-randomized, open-label, single-dose Mass Balance Study. The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Participants will get a single dose of \[14C\]GZR18 injection
Study site 01
Beijing, China
Primary Outcome Measure
The total radioactivity recovery at each interval and the cumulative total radioactivity recovery in excreta (urine and feces).
Time frame: Through study completion, an average of 1 year
Primary Outcome Measure
Percentage of parent drug and its metabolites (if applicable) in plasma in total radioactivity exposure in plasma; percentage of parent drug and its metabolites (if applicable) in urine and feces in administered dose; identification of major metabolites in plasma, urine, and feces.
Time frame: Through study completion, an average of 1 year
Primary Outcome Measure
Peak Plasma Concentration (Cmax)
Time frame: Through study completion, an average of 1 year
Primary Outcome Measure
Area under the plasma concentration versus time curve (AUC)
Time frame: Through study completion, an average of 1 year
Primary Outcome Measure
Ratio of total radioactivity concentration in whole blood to plasma
Time frame: Through study completion, an average of 1 year
Primary Outcome Measure
Time-To-Peak(Tmax)
Time frame: Through study completion, an average of 1 year
Primary Outcome Measure
Mean Residence Time
Time frame: Through study completion, an average of 1 year
Primary Outcome Measure
Half-Life Period(T1/2)
Time frame: Through study completion, an average of 1 year
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PK parameters of GZR18 and its metabolites (if applicable) in plasma
Peak Plasma Concentration (Cmax)
Time frame: Through study completion, an average of 1 year
Safety Evaluation:Clinical safety evaluation during the study
weight and height will be combined to report BMI in kg/m\^2
Time frame: Average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Area under the plasma concentration versus time curve (AUC)
Time frame: Through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Time-To-Peak(Tmax)
Time frame: through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Mean Residence Time
Time frame: through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Half-Life Period(T1/2)
Time frame: through study completion, an average of 1 year
Safety Evaluation:Clinical safety evaluation during the study
laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, stool analysis + occult blood and thyroid function)
Time frame: Average of 1 year