healthy subjects
Conditions
Interventions
1:Phase 1: single oral administration of 0.16 g fenofibrate tablets (III) produced by Guangzhou Bai Sai Luo Pharmaceutical Co., Ltd
Phase 2: France Leibo Funi Pharmaceutical Company The relative bioavailability of fenofibrate tablets (III) (0.16 g / tablet)
2:Phase 1: France Leibo Funi Pharmaceutical Company The relative bioavailability of fenofibrate tablets (III) (0.16 g / tablet)
Phase 2: single oral administration of 0.16 g fenofibrate tablets (III) produced by Guangzhou Bai Sai Luo Pharmaceutical Co., Ltd
Sponsors
Clinical Pharmacology Institution, Xiang Ya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Gender: Male healthy subjects; 2.Age:More than 18 years of age (including 18 years of age); 3.Body Weight:No less than 50Kg and body mass index [BMI = weight (kg) / height 2 (m2)] in the range of 19 to 26 (including the boundary value); 4.Subjects must have informed consent to this study prior to trial and voluntarily sign a written informed consent form; 5.Subjects are able to communicate well with the investigator and are able to complete the study in accordance with the study.
Exclusion criteria
Exclusion criteria: 1. Screening period physical examination, vital signs, ECG and laboratory tests (blood, urine, blood clotting, blood biochemistry, etc.), the researchers to determine the clinical significance of abnormal; 2. Abnormal blood clotting or a known tendency to severe bleeding; 3. Previous suffering from gastrointestinal and liver, kidney disease and thus affect the absorption or metabolism of drugs; 4. Allergy to this ingredient and any ingredients in the excipient, or a history of allergy to the same drug; 5. Those who can not comply with a unified diet (such as the standard meal food intolerance, etc.) 6. Hepatitis B surface antigen positive, or hepatitis C antibody positive, or Treponema pallidum antibody positive, or HIV antibody positive test; 7. Male (or her partner) subjects are reluctant to Take protective measures for contraception during the study period; 8. Vaccines or live attenuated vaccines have been inoculated within 6 weeks prior to the trial or they are planned to be vaccinated within 6 weeks of treatment or during the last study drug; 9. Within 6 months before the trial, the subject had any infection requiring the hospitalization, the need for parenteral antibiotic therapy or the investigator to determine the opportunistic infection; 10. High-risk people who are suffering from immune diseases or who may have immune system dysfunction, such as primary relatives with primary immunodeficiency disease; 11. Have a history of recurrent herpes zoster, or a history of disseminated herpes zoster, or a history of herpes simplex herpes; 12. Those who have history of malignant tumor; 13. Tea, coffee or caffeine-containing beverages(Eg, more than 8 cups per day, 1 cup = 200 ml); or take in any food or drink containing caffeine(such as coffee,, Tea, chocolate, etc.) within 48 hours of the first medication ; 14. During the first 48 hours of treatment, intake of any xanthine or grapefruit ingredients of the drink or food; 15. The acceptable range of alcohol testing is: 0 ~ 3mg / 100ml; previous alcoholism, or drinking within 6 months before the test (more than 14 units of alcohol per week [1 unit = 360ml beer or 45ml alcohol 40% Spirits or 150ml wines]); 16. Smoking is more than 5 cigarettes in the first 3 months of screening and no smokers are prohibited during the trial period; 17. To study the first drug addiction test before the first drug or 1 year before the history of drug abuse history (such as benzodiazepine, marijuana, cocaine, morphine, barbiturates, amphetamines, etc.); 18.Those who had take any prescribed drugs,over-the-counter drugs or health products(except for regular vitamin supplements) before the first 14 days of the trial. Or take CYP3A4, CYP2C19 inhibitors (eg ketoconazole, fluconazole), CYP3A4 Inducers (such as rifampicin), immunosuppressive drugs (such as azathioprine, tacrolimus, cyclosporine A) or any drug that interacts with moxifloxacin before the first 30 days of the trail ; 19. Those who participated in any drug clinical trials and who had taken clinical trials before the first three months of the trial; 20. Blood donation or blood composition is planned within three months of the trial or within three months of the study or after the end of the study; 21. Those who had critical illnesses or had undergone critical surgery within 1 year before the trial; 22. The researcher considers that it is not advisable to participate in other cases of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the curve; | — |
Countries
China
Contacts
Public ContactZhirong Tan
Clinical Pharmacology Institution, Xiang Ya Hospital, Central South University
Outcome results
None listed