Nausea and vomiting associated with chemotherapy
Conditions
Interventions
Test Group 1:2min intravenous injection of aprepitant injection (test formulation)
Test Group 2:30min intravenous infusion of aprepitant injection (test formulation)
Reference Group:30min intravenous infusion of aprepitant injection (reference formulation)
Sponsors
Shulan (Hangzhou) Hosipital
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent before the test, and fully understand the test content, process and possible adverse reactions; 2. Be able to complete the study in accordance with the requirements of the experimental protocol; 3. Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before the first administration to 6 months after the last administration; 4. Male and female subjects aged 18-59 years (including cut-off value); 5. The weight of male subjects should not be less than 50 kg, and the weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/ height 2 (m2), BMI in the range of 18.0-28.0 kg/m2 (including the critical value); 6. Normal or abnormal physical examination and vital signs with no clinical significance
Exclusion criteria
Exclusion criteria: 1. More than 5 cigarettes per day in the 3 months before the study; 2. Allergic history to the test drug, allergic constitution (allergic to two or more drugs and food, especially soybean, alcohol, eggs); 3. More than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) during the 6 months prior to screening, or who could not guarantee to abstain from drinking during the study; 4. Blood donation or massive blood loss (>450 mL) within 3 months before screening; 5. Taking drugs which changes of liver enzyme activity and has interaction with aprepitant (such as pimodize, benzodiazepines, dexamethasone, methyl prednisolone, warfarin, vinblastine and vincristine, ifosfamide, hormonal contraception, diltiazem, ketoconazole, itraconazole, nefazodone, peunus persica, clarithromycin,ritonavir, nelfinavir, rifampin, carbamazepine, phenytoin sodium); 6. Taking any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines, or vaccinated within 14 days prior to screening; 7. Drinking excessive amounts of tea, coffee and/or caffeinated beverages per day within 3 months before screening (more than 8 cups, 1 cup = 250 mL); 8. Special dietary requirements, can not accept the unified diet, or have significant changes in diet or exercise habits recently; 9. Taking research drugs or participating in drug clinical trials within 3 months before administration; 10. ECG abnormalities with clinical significance; 11. Lactated or positive serum pregnancy results for female subjects during the screening period or during the study; 12. Abnormal clinical laboratory tests or other diseases with clinical significance (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases); 13. Viral hepatitis (including hepatitis B and C), positive HIV antibody, positive syphilis antibody; 14. Acute illness occurred from the screening stage to the study medication; 15. Consumption of pitaya, mango, grapefruit, lime, star fruit or food or drink prepared from them within 24 hours before administration; 16. Consumption of chocolate, any caffeinated or xanthine-rich food or drink within 24 hours prior to administration; 17. Consumption of any alcoholic product within 24 hours prior to adminisration; 18. Positive result of alcohol or drug screening or a history of substance abuse within the past five years; 19. Subject to be unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak concentration;area under concentration versus time curve 0-t;area under concentration versus time curve 0-8;Plasma concentrations at 12h after initiation of dosing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration;elimination rate constant;half-life period;percentage of residual area under concentration versus time curve; | — |
Countries
China
Contacts
Public ContactChen Guilin
Outcome results
None listed