Influenza
Conditions
Interventions
Dose group 1:Peramivir inhalation solution (initially 20mg) administered by both oral or face mask nebulized inhalation
Dose group 2:Two cycles of cross-administration of paramivir inhalation solution or paramivir sodium chloride injection
Dose group 3:3:1 randomized, 9 received peramivir inhalation solution and 3 received placebo administration
Multiple dosing group:3:1 randomized, 9 received peramivir inhalation solution and 3 received placebo administration
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled: 1) Age = 18 years, both sexes; 2) Body weight = 50.0 kg for males and 45.0 kg for females, with a body mass index (BMI) between 19 and 26 kg/m2, including the threshold value; 3) Subjects voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1) Persons with any previous or current clinically significant circulatory, endocrine, neurological, gastrointestinal, respiratory, genitourinary, hematological, immunological, psychiatric or metabolic abnormalities or any other disease that could interfere with the test results; 2) History of allergy to drugs, food or other substances; 3) Surgical procedures within 4 weeks prior to the test or planned surgical procedures during the study period; 4) Any drug or health product (including herbal medicine) taken within 14 days prior to the test; and 5) Any drug that inhibits or induces hepatic metabolism of drugs (e.g., inducers such as barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the trial; 6) Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial; 7) Those who donated blood or lost a large amount of blood (=200mL, excluding blood loss during menstruation in women), received blood transfusion or used blood products within 3 months prior to enrollment; 8) Pregnant or lactating women, and those who cannot use one or more non-pharmaceutical contraceptive measures during the volunteer trial; 9) Those who have special dietary requirements and cannot comply with the uniform diet; 10) Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL); 11) Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or those who could not stop using any tobacco products during the trial or had a positive test result; 12) Alcoholics or regular drinkers within 6 months prior to the test, i.e. drinking more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of 40% alcohol spirits or 150mL of wine) or unable to stop using any alcohol-containing products during the test; (13) Positive urine drug screen or use of soft drugs (e.g., marijuana) in the 3 months prior to the test or hard drugs (e.g., cocaine, phencyclidine, etc.) in the 1 year prior to the test; 14) Abnormal vital signs (systolic blood pressure =90mmHg or >140mmHg, diastolic blood pressure 90mmHg; heart rate 100bpm) or clinically significant abnormalities on physical examination, laboratory tests, or orthogonal chest X-ray (as determined by the clinical investigator); and 15) Difficulty in venous blood collection or intolerance to intravenous drip or venipuncture, or history of needle sickness or blood sickness; 16) clinically significant ECG abnormalities or QTcF = 450ms in men and QTcF = 470ms in women; (17) Abnormal pulmonary function (measured first second expiratory volume [FEV1] / FEV1 estimated value = 80% or measured force spirometry [FVC] / FVC estimated value = 80%); 18) Previously diagnosed chronic obstructive pulmonary disease (COPD), asthma, or other clinically significant lung disease, or a history of acute upper or lower respiratory tract infection requiring intravenous anti-microbial agents or other hospitalization within 3 months; 19) Those who have consumed special foods (e.g. grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine-containing food or drink) within 48 hours prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;urine PK;fecal sample PK; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions;Physical examination;vital signs;laboratory test;Electrocardiogram; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Qingnan He
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Outcome results
None listed