tgrx-326 pharmacokinetic food effect bioavailability study

Conditions: Non Small Cell Lung Cancer

Summary: 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.

Eligibility criteria:
inclusion criteria: * able to understand the purpose, methods and possible adverse events of the study and agree to volunteering consent before the start of study * healthy subject; male or female * age between 18 and 55 (inclusive) * body mass index (bmi) between 19.0 and 26.0 (inclusive), male weight \<=50 kg, female weight \<=45 kg * normal/ clinically insignificant test results (including physical exam, laboratory tests, 12-lead ecg, chest x-ray, etc.) * participant/partner of the participant does not have plans for child bearing from screening until 6 months after study, and is willing to take contraceptive measures during study period and for 6 months, and does not have plans to donate sperm/egg during the said period exclusion criteria: * history of allergic reactions, or allergic to any components to the study drugs that by investigator's judgement unsuitable for the study * any clinically significant conditions that could affect study outcomes, safety or compliance * history of major surgery within 3 months before first dose, or have plans to receive surgery during the study, or history of any surgery that could affect drug absorption, distribution, metabolism and excretion * have difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness * history of substance abuse * have special food requirement or cannot follow food requirement of the study, or lactose intolerant * use of any investigational drug or participation of any clinical study (for drug or medical device) within 3 months before first dose, or cannot participate the study in person/on site * history of blood donation, blood loss (\>= 400 ml, excluding normal blood loss during female menstrual period), or reception of blood transfusion within 3 months before screening * history of daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study * history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or cannot avoid alcohol consumption during study * history of large tea/coffee/caffeinated drink intake (more than 8 cups per day) within 3 months before first dose * history of irregular dietary schedule within 1 months of first dose (including, dieting, overeating, low sodium intake, etc.) * use of any prescription / over-the-counter drug, or chinese herbal medication, or health supplementary products within 14 days of test article administration * vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period * any one positive result for hepatitis-b surface antigen, hepatitis c antibody, hiv antibody or syphilis antibody * alcohol breathing test results of \> 0.0 mg/100ml for blood alcohol concentration * positive test results on substance use (including, morphine, methylamphetamine, ketamine, tetrahydrocannabinol, methylene-dioxy-methyl-amphetamine) * female in pregnancy or breastfeeding period, or positive pregnancy test result * history of unprotected sexual activities within 14 days before first dose * consumption of food or drink rich in caffeine/xanthine (such as chocolate, coffee, tea, coke) or food/food product of grapefruit, dragon fruit, mango, tangerine, or any food that could affect drug absorption, distribution, metabolism and excretion * any reasons that is deemed unsuitable for study participation as determined by investigator