None listed
Conditions
Interventions
3:The first cycle on an fed condation with test product
4:The first cycle on an fed condation with reference product
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over the aged of 18 (including the age of 18); 2. At least 50kg for male, 45kg for female with a Body Mass Index (BMI) between 18-28kg/m2, inclusive(BMI = kg/m2); 3. Healthy status: no heart, liver, kidney, digestive system, nervous system, mental disorders and metabolic disorders and other medical historyPhysical examination revealed blood pressure, heart rate, electrocardiogram respiratory system, liver, kidney function and blood as normal or abnormal no clinical significance; 4. No birth plan during the study and within 6 months after the study; 5. To be able to understand and provide written informed consent and voluntary consent to participate in the study; 6. To be able to complete the study in compliance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Clinical laboratory examination were abnormal clinical significancce or other clinical findings show that there are cllinical significance of the following diseases (including but nnot limited to the gastrointestinal tractkidney liver neural blood endocrine tumor lung immune mental or cardiovascular disease; 2. Abnormal ECG have clinical significance; 3. Have hepatitis (including hepatitis B and C) and tested positive for HIV/AIDS screening; 4. The subjects Screened positive for drug and alcohol or had has a history of substance abuse in the past five years or used drugs 3 months before the study; 5. Consume more than 5 cigarettes per day or the equivalent within three months before the test; 6. Have known allergies to compounds related to Linezolid; 7. The subjects have a history of drug and /or alcohol abbuse (alcohol in take 14 units weekly:1 unit=285ml beer,or 25ml liquor,or 1 cup of wine); 8. Have a blood donation or blood loss (450 ml)within three months before taking research drugs; 9. If the subjects taking any drugs of changing the liver enzyme activity or not within 28 days before taking medicine; 10. Have taken any prescription,non-prescriiption drugs, any vitamin products or herbs within 14 days prior to the study; 11. Take over special diet (including pitava,mango,pomelo,and/or xanthine diet)or taking strenous exercise, or the other factors that affect drug absorption,distribution, metabolism and excretion within 2 weeks before the test; 12. Subjects intake of chocolate,any caffeinated,or xanthine-containing food or drinks within 48 hours before taking study drugs; 13. Use any alcoholic products within 24 hours before taking study medication; 14. Whether to take study drug or participated in drug clinical trials within three months before the study; 15. Have a history of gastrointestinal diseases about difficulty swallowing or any effects of drug absorption; 16. If there were any major changes or not on a diet or exercise habits recently 17. Acute illness happened before the screening stage prior to the study or before taking study drugs; 18. Suffering from any increase in the risk of bleeding disorders, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers, etc. 19. Female subjects who were breast feeding or pregnancy in the screening period or during the test process. 20. The subjects had a disease history of asthma or seizures. 21. Any subject who is not suitable to enroll the study by the investigators judgments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;Cmax; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed