TGRX-326 Pharmacokinetic Drug Interaction

Korábbi kezelés

• use of substance that affects CYP3A4 enzyme activity with 30 days before screening
• use of any drug within 14 days of test article administration
• use of any investigational drug or participation of any clinical study within 3 months before screening
• vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period
• history of major surgery within 6 months before screen, or have unhealed surgical wounds.
• daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study
• history of certain food intake 2 weeks before screening, and/or use of more than 8 cups of tea/coffee/grapefruit juice
• history of unprotected sexual activities within 1 month before screening
• history of blood donation or blood loss within 3 months before screening, or have plans to donate blood within 1 month after the study

Más betegség

• any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody
• history of cardiovascular diseases
• history of mental conditions including depression, aggressive behaviours, epilepsy, etc.
• any clinically significant conditions that investigator believes could affect study outcomes
• history of allergic reactions, or allergic to any components to the study drugs, or have food allergy/special requirement for food that forbids the subject to follow food requirements for the study
• history of substance abuse, or positive drug results at screening

Laborértékek

• abnormal and clinically significant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.)
• prolongation in QT interval
• history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or alcohol breath test of > 0.0 mg/dl at screening

Egyéb

• positive pregnancy test results, or pregnant/breast-feeding females
• have plans for child bearing during study period and for 6 months after study, or disagree to take contraceptive measures during study period and for 6 months after study
• any reasons that is deemed unsuitable for study participation as determined by investigator

• healthy subject; male or female
• Age between 18 and 45 (inclusive)
• body mass index (BMI) between 19.0 and 26.0 (inclusive)
• agree to consent
• able to communicate with investigator well and complete the study according to study protocol