TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

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