A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment
This study is designed as single-center, randomized, open-label, 3-cycle, 6-sequence and crossover design to evaluate 1) food effect on PK profile of TGRX-326; 2) effect of different specifications of TGRX-326 on human bioavailability. Safety for food effect on TGRX-326 and safety for different TGRX-326 specifications were also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
for cycle 1 treatment: participants are given the oral treatment specification (60 mg \*1 pill)
for cycle 1 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)
for cycle 1 treatment: participants are asked to take the drug fasted
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China
Plasma Cmax
Maximum concentration of TGRX-326 measured in plasma
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Plasma AUC(0-t)
Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-326 as measured in plasma
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Plasma AUC(0-inf)
Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Plasma Tmax
Time to maximum concentration of TGRX-326 measured in plasma
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
terminal elimination rate constant (lambda-z)
terminal elimination rate constant calculated from plasma TGRX-326 concentrations
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Elimination half-life (T1/2-Z)
Time for TGRX-326 to decrease from maximum plasma concentration to half of maximum plasma concentration
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
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for cycle 1 treatment: participants are asked to take the drug after food intake
for cycle 2 treatment: participants are given the oral treatment specification (60 mg \*1 pill)
for cycle 2 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)
for cycle 2 treatment: participants are asked to take the drug fasted
for cycle 2 treatment: participants are asked to take the drug after food intake
for cycle 3 treatment: participants are given the oral treatment specification (60 mg \*1 pill)
for cycle 3 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)
for cycle 3 treatment: participants are asked to take the drug fasted
for cycle 3 treatment: participants are asked to take the drug after food intake
AUC(%Extrap)
Calculated percentage of Area under curve for AUC(0-inf) that is from last measurable timepoint ot infinity, calculated based on TGRX-326 plasma concentration over time curve.
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Plasma volume of distribution (Vz/F)
Apparent volume of distribution of TGRX-326 in plasma
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Plasma clearance (CL/F)
Apparent clearance of TGRX-326 in plasma
Time frame: During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Adverse events/serious adverse events
to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: through completion of the study, a total duration of 37 days