A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678
This study is designed as single-center, single-dose, randomized, open-label and parallel-comparison to evaluate food effect on PK profile of TGRX-678 in healthy subjects. Safety and tolerability of the drug is also evaluated during study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
All participants are given TGRX-678 orally at 240 mg
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Plasma Tmax
Time to maximum concentration (Tmax) of TGRX-678 measured in plasma
Time frame: During Treatment period (Day 1 to Day 43)
Plasma Tlag
Time between drug administration to drug absorption (Tlag) as indicated by TGRX-678 plasma concentration
Time frame: During Treatment period (Day 1 to Day 43)
Plasma Cmax
Maximum concentration (Cmax) of TGRX-678 measured in plasma
Time frame: During Treatment period (Day 1 to Day 43)
Plasma AUC(0-t)
Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-678 as measured in plasma
Time frame: During Treatment period (Day 1 to Day 43)
Plasma AUC(0-inf)
Area Under drug concentration-time curve from time 0 to infinity for TGRX-678 as measured in plasma
Time frame: During Treatment period (Day 1 to Day 43)
AUC(%Extrap)
Calculated percentage of Area under curve for AUC(0-inf) that is from last measurable timepoint ot infinity, calculated based on TGRX-678 plasma concentration over time curve.
Time frame: During Treatment period (Day 1 to Day 43)
Half Life (T1/2)
Time for TGRX-678 to decrease from maximum plasma concentration to half of maximum plasma concentration
Time frame: During Treatment period (Day 1 to Day 43)
Plasma volume of distribution (Vz/F)
Apparent volume of distribution of TGRX-678 in plasma
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Time frame: During Treatment period (Day 1 to Day 43)
Plasma clearance (CL/F)
Apparent clearance of TGRX-678 in plasma
Time frame: During Treatment period (Day 1 to Day 43)
Adverse Events (AE)
To record adverse events to participants during study participation
Time frame: Starting from consent signing and until end of Treatment period (Day 1 to Day 43)