food effect on drug PK
Conditions
Interventions
A:Three cycles: fasting T (150mg * 2 tablets) - improved fasting R (250mg) - high fat postprandial T (150mg * 2 tablets)
B:Three cycles: improved fasting R (250mg) - high fat postprandial T (150mg * 2 tablets) - Fasting T (150mg*2 tablets)
C:Three cycles: high fat postprandial T (150mg * 2 tablets) - fasting T (150mg * 2 tablets) - improved fasting R (250mg)
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Age 18 to 45 years (including boundary value), male; (2) Male subjects have a body weight >= 50 kg and a body mass index (BMI) in the range of 19.0 to 26.0 kg/m 2 (body mass index = body weight (kg) / height 2 (m2)), including the boundary value; (3) There was no unprotected sexual behavior within 2 weeks before screening, and there was no birth, donation program and voluntary physical contraception during the trial period and within 3 months after the trial; (4) Know in detail the nature, significance, possible benefits of the test, possible inconvenience and potential risks before the test. Can understand the procedures and methods of this study, are willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who are known to be allergic to the study drug or excipient, or who have a specific history of allergies (allergic asthma, urticaria, eczema, etc.), or allergic persons (such as those who are allergic to two or more drugs, food or pollen); (2) Any clinically serious disease, such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other disease that can interfere with the test results. (3) Those who have undergone major surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study period; (4) Those who have taken any drug within 14 days before the test (including vitamins and Chinese herbal medicines); (5) Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI Antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, clarithromycin, nefazodone, Tonavir and atazanavir); (6) Any clinical trial drug or any clinical trial of the drug taken within 3 months before the test; (7) Donoring blood or a large amount of blood loss (>=200mL) within 3 months before the test, receiving blood transfusion or using blood products; (8) Those who have special requirements for diet and who cannot follow the unified diet; (9) Special foods related to the test (including tobacco, alcohol, caffeine, etc.) cannot be avoided within 48 hours before the first study drug administration and during the test period; (10) Drinking excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 200 mL) daily for 3 months before the test; (11) smokers or smokers with an average daily smoking volume of more than 5 in the first 3 months of the trial; (12) Alcoholics or those who regularly drink alcohol within 6 months prior to the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or alcohol Gas positive (13) Drug abusers who have used soft drugs (such as marijuana) 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; (14) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or physical examination, electrocardiogram, laboratory examination, etc. Meaning (subject to the judgment of the clinician); (15) One or more positive tests for hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum antibody; (16) Other reasons The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma drug concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital of Central South University
Outcome results
None listed