a bioquvalence study,Oseltamivir Phosphate indicated for treatment and prophylaxis of influenza
Conditions
Interventions
1:Yichang HEC Changjiang Pharmaceutical Co.,Ltd. produced OSELTAMIVIR PHOSPHATE CAPSULES 7.5MG Under fasting and fed condition, respectively
2:reference product OSELTAMIVIR PHOSPHATE CAPSULES 7.5MG Under fasting and fed condition, respectively
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Willing to give voluntary written informed consent for participation in the trial,and well understand about the study content ,procedures and averse reaction of the drug may occur during the trial; 2. To be able to comply with the study procedures; 3. If of child bearing potential( both male and felmale subjects) is willing to use a suitable and effective barrier contraceptive method during the study andat least 6 months after study participation; 4. Healthy male and female adult human volunteers between l8 to 65 years of age (both inclusive); 5. The weight of a male subject is no lower than 50kg,The female is no lower than 45kg,and having a Body Mass Index (BMI) between 18 to 28 (both inclusive), calculated as weight in kg / height in m2; 6. Not having history of any disease or disorder about the cardiovascular, hepatic, renal, gastrointestinal, nervous, endocrine or any other body system; 7. The results of clinical laboratory evaluations and physical examination are normal or having no clinically significant.
Exclusion criteria
Exclusion criteria: 1. Smokers, who smoke 5 or more than 5 cigarettes 1 day within 3 months prior to the study; 2. Known hypersensitivity or idiosyncratic reaction to Oseltamivir Phosphate or any related excipients; 3. History of harmful use of Drugs and alcohol (Alcohol consumption of more than 14 standard drinks per week. A standard drink is defined as 285ml of beer or 25ml of distilled spirits or 100ml of wine); 4. Donation of blood or suffering massive blood loss (more than 450ml) within 3 months prior to receiving the first dose of study medicine; 5. Any history of asthma or epileptic seizure; 6. Having difficulty of swallowing or any history of gastrointestinal diseases that affect drug absorption; 7. Having any disease that increasing risk of hemorrhagic, such as hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc.; 8. Taken any drug that change the activity of liver enzyme within 28 days prior to dosing; 9. Taken any prescription drugs, over-the-counter medications, vitamins or herbal products within 14 days prior to dosing; 10. Taken any special diet (including the pitaya, mango, pomelo,and/or food and drink that contain xanthine etc.), exercise strengly, or having other factor that affect drug absorption, distribution, metabolism and excretion within 2 weeks prior to the study; 11. Taken any CYP3A4, P - gp or Bcrp inhibitors or inducers, such as itraconazole, ketoconazole or dronedarone etc.; 12. Having any significant change on diet or exercise habit; 13. receipt of an investigational medicinal product or participation in a drug research study within 3 months prior to receiving the first dose of study medicine; 14. Having clinical significant abnormal in 12-lead ECG; 15. a positive serum pregnancy outcomes or nursing mothers in screening or during the study; 16. Clinical laboratory evaluations and physical examination are clinically significant abnormal, or having any clinically significant disease Including but not limited to the gastrointestinal, hepatic, renal, nervous, hematic, endocrine, neoplastic, neoplastic, immune, psychic or cardiovascular disease; 17. A positive test result for HIV ,HCV and HBV antibody; 18. Having acute disease in stage of screening or prior to dosing; 19. Consumption of any food and drink containing caffeine, chocolate, or xanthine within 48 hours prior to dosing; 20. Consumption of alcohol or alcohol products within 48 hours prior to dosing; 21. testing positive in prestudy drug scans and alcohol examinition,or history of drug addiction within 5 years, or Use of any recreational drugs within 3 months prior to study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;Vd/F;CL/F;F; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed