Influenza
Conditions
Interventions
Fasting Group ?(T-R):Subjects in the T-R group received 75 mg (12.5 mL, 6 mg/mL) of the test formulation (T) in a fasting single dose in the first cycle and 75 mg (12.5 mL, 6 mg/mL) of the reference f
Fasting Group ?(R-T):Subjects in the R-T group received 75 mg (12.5 mL, 6 mg/mL) of the reference formulation (R, Tamiflu) orally in a fasting single dose in the first cycle, 75 mg (12.5 mL, 6 mg/mL)
Fed Group ?(T-R):Participants in the T-R group received 75 mg (12.5 mL, 6 mg/mL) of the test formulation (T) in a single oral dose 30 ± 0.5 min after the start of a high-fat and high-calorie meal in c
Fed Group ?(R-T):Subjects in the R-T group received a single oral dose of the reference formulation (R, Tamiflu) 75 mg (12.5 mL, 6 mg/mL) 30 ± 0.5 min after the start of the high-fat and high-calorie
Sponsors
Hangzhou Red Cross Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be included, all eligibility criteria were met: 1) The subjects were fully aware of the purpose, nature, methods, and possible adverse reactions of the trial, volunteered to serve as subjects, and signed an informed consent form before the start of any study procedure. 2) the age of 18 one full year of life above (including 18 one full year of life) of healthy male and female subjects; 3) male weight 50.0 kg, or female weight 45.0 kg or more; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including critical value), BMI= weight (kg)/height 2 (m) 2; 4) of vital signs, physical examination, 12 lead electrocardiogram (ecg) and laboratory tests (blood routine, routine urine and blood biochemistry, screening, blood coagulation function, women pregnancy) normal or research doctors determine abnormal without clinical significance; 5) The subjects had no plans to have children within 3 months after signing the informed consent and voluntarily took effective contraceptive measures, and had no plans to donate sperm or eggs.
Exclusion criteria
Exclusion criteria: Those who met one of the following exclusion criteria were excluded: 1) Patients who were allergic to oseltamivir phosphate or its accessories, or had allergic constitution (such as asthma, urticaria, eczema and other allergic diseases), or had a history of drug or food allergy and were judged by the investigators to be unsuitable for enrollment; 2) have any disease or medical history that may affect the safety of the trial, affect the internal course of the drug, or may reduce adherence, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematologic, endocrine, oncologic, immunologic, psychiatric, or cardio-cerebrovascular diseases; 3) patients who underwent surgery within 3 months before screening or planned to undergo surgery during the study, and those who underwent surgery that may affect drug absorption, distribution, metabolism, or excretion; 4) difficult venipuncture, or can not tolerate venipuncture, or have a history of dizzy with needles and blood; 5) having a history of drug use or drug abuse, or screening positive for drug abuse (morphine, methamphetamines, ketamine, tetrahydrocannabinol, dimethylenedioxyamphetamine); 6) do you have any special dietary requirements, or, fructose, sorbitol, lactose intolerance, or drink milk easy to diarrhea, or during the test cannot observe unified diet; 7) screening within 3 months before clinical trials involved in other drugs or equipment or not to participate in clinical subjects; 8) within 3 months prior to screening blood donation (including the component of blood) or massive blood loss (or 400 mL, female except normal physiology period of blood), or receive a blood transfusion or use of blood products; 9) who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study; 10) drank 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) in the 3 months before screening, or could not abstain from alcohol during the study; 11) consuming excessive amounts of tea, coffee or caffeine-rich beverages (> 8 cups, 1 cup =250 mL) per day in the previous 3 months; 12) within a month before the screening have irregular diet behavior (such as diet, gluttony, low sodium, etc.); 13) who had used any prescription drug, over-the-counter drug, herbal medicine, or health supplement within 14 days before screening; 14) were vaccinated within 1 month before screening or were planning to be vaccinated during the trial; 15) blood alcohol concentration (BAC) > 0 mg/100 mL; 16) the female subjects were pregnant or lactating; 17) cannot promise in the first cycle and the second cycle in stage I ward to check-in without eating during 3 days before the dragon fruit, mango, pomelo, lime, carambola, or by the preparation of food or drink, no caffeine intake of chocolate and (such as coffee, strong tea, coke, etc.) of beverage; 18) other conditions judged by the investigator to be ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentrations of oseltamivir(Cmax);Area under the curve for the time from administration to the lowest detectable blood concentration(AUC0-t);Area under the curve for the time from drug administration to extrapolation to infinity(AUC0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration(Tmax);Elimination rate constant(?z);Terminal terminal half-life was eliminated(t1/2z);Residual area percentage(AUC_%Extrap); | — |
Countries
China
Contacts
Public ContactYing Wang
Hangzhou Red Cross Hospital
Outcome results
None listed