SARS-CoV-2
Conditions
Interventions
Test preparation (T):DEXAMETHERVIR FUMARATE TABLETS 110 MG
Reference formulation (R):Entamivir Fumarate Tablets (trade name: XOCOVA, strength: 125 mg)
Sponsors
Wannan Medical College Yijishan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. healthy volunteer subjects, male and female (both male and female), aged 18 years or older (including 18 years); 2. male subjects weighing not less than 50.0 kg, female subjects weighing not less than 45.0 kg, body mass index (BMI) within the range of 19.0 ~ 26.0 kg/m2 [BMI = weight (kg)/height 2 (m2)] (including the critical value); 3. subjects (including male subjects) are willing to have no fertility plan and voluntarily take effective non-drug contraceptive measures (see the Appendix) and no sperm donation and egg donation plan from screening to 6 months after the last dose of the study drug; 4. sign the informed consent form before screening, and fully understand the content, process and possible adverse reactions of the trial, and can complete the study according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. diseases that occur or are occurring before screening with abnormal clinical manifestations and need to be excluded, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive tract system (any history of gastrointestinal diseases affecting drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, immune system diseases; 2. vital signs examination, physical examination, clinical laboratory tests (blood routine, urine routine, blood biochemistry), coagulation function, immune examination, pregnancy test (only women), 12-lead electrocardiogram, chest X-ray examination, which are judged by the investigator to show abnormal clinical significance; 3. patients who have undergone surgery or plan to undergo surgery during the study within 3 months before screening, and patients who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion; 4. patients who have a history of clinical allergy to food, drugs, or are known to be allergic to enseltamivir fumarate or any component of this product; 5. patients who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health products within 2 weeks before screening; 6. Patients who have received vaccination within 1 month before screening (special: new coronavirus vector vaccine for 1 month, inactivated and recombinant vaccine for 2 weeks), or plan to receive vaccination during the study; 7. The average weekly alcohol consumption within 3 months before screening is more than 14 units (1 unit alcohol ˜ 360 mL beer or 45 mL spirits or 150 mL wine with 40% alcohol content),Or can not abstain from alcohol during the trial; 8. the average daily smoking of more than 5 cigarettes within 3 months before screening, or can not stop using any tobacco products during the trial; 9. blood donation including blood components or massive blood loss (= 400 mL) within 3 months before screening; 10.History of drug abuse within 6 months prior to screening; 11.Drug use within 3 months prior to screening; 12.Use of any drugs that inhibit or induce hepatic metabolism of drugs (eg, inducers – barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors – SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) within 28 days before screening; 13.Those who have participated in other drug clinical trials or who have not come to participate in clinical trials within 3 months before screening; 14.Consumption of excessive tea, coffee, and/or caffeinated beverages (average of more than 8 cups, 1 cup ˜ 250 mL) per day on average during the 3 months before screening; 15.Those who have special requirements for diet and cannot accept unified diet; 16.Dysphagia; 17.Patients with a history of infectious diseases (except for a history of novel coronavirus infection); 18.Lactose intolerance (those who have had diarrhea from drinking milk); 19.Patients who cannot tolerate venipuncture or have a history of fainting or bloody halo; 20.Female subjects who are lactating; 21.Patients who are not suitable for participating in the clinical trial according to the investigator 's judgment.Those who meet any of the above conditions shall not be enrolled as volunteer subjects. 1. there are concomitant drugs, acute diseases, smoking, drinking, strenuous exercise befo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine pregnancy, blood pregnancy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical laboratory tests (hematology, blood biochemistry, urinalysis); | — |
Countries
China
Contacts
Public ContactJia Yuanwei
Wannan Medical College Yijishan Hospital
Outcome results
None listed