Influenza
Conditions
Interventions
The fasting group:Period 1: Study participants were admitted to the clinical research ward 2 days prior to drug administration. They were required to fast for at least 8 hours before dosing. On the tr
Postprandial group:Period 1:Study participants were admitted to the clinical research ward 2 days prior to the trial. They were required to fast for at least 8 hours before consuming the high-fat meal
Sponsors
The First Affiliated Hospital of Guilin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: To be eligible as a research participant, the following criteria must be met: 1. Chinese healthy research participants aged between 18 and 60 years old (inclusive of the boundaries), both male and female are acceptable; 2. Male weight >= 50 kg, female weight >= 45 kg, with a body mass index (BMI) within the range of 19.0 - 26.0 kg/m^2 (BMI = weight (kg) / height^2 (m)), including the boundaries; 3. Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions; 4. The research participants can communicate well with the researchers and understand and comply with all the requirements of this study. Those who do not meet any of the above conditions shall not be selected as research participants.
Exclusion criteria
Exclusion criteria: Study participants meeting one or more of the following criteria will be excluded from the trial: 1. Having participated in any clinical drug trial and received investigational drugs within 90 days prior to the current trial; or having participated in a drug trial with an interval shorter than 10 half-lives of the previously administered investigational drug. (Medical interview + network-based screening) 2. Having a history of hypersensitivity to any component of the study drug, or a documented history of allergies to drugs, foods, or other substances. (Medical interview) 3. Having dysphagia; or a history of chronic or active gastrointestinal diseases (e.g., esophageal disorders, gastritis, gastric ulcer, enteritis), active gastrointestinal bleeding, or gastrointestinal surgery within the past 3 years, which is deemed clinically significant by the investigator at the time of screening. (Medical interview) 4. Having a history of diseases involving the respiratory, cardiovascular, endocrine, urinary, nervous, hematological, or immune systems (including personal or familial history of hereditary immunodeficiency), or metabolic disorders, which is deemed clinically significant by the investigator at the time of screening. (Medical interview) 5. Having orthostatic hypotension; or a history of intolerance to venipuncture, hematophobia, or trypanophobia; or experiencing recurrent difficulties with venous blood collection. (Medical interview) 6. Having undergone any surgery within 6 months prior to study drug administration that, in the investigator’s judgment, may affect drug absorption, distribution, metabolism, or excretion; or having undergone any surgical procedure within 4 weeks prior to the trial; or having a planned surgical intervention during the study period. (Medical interview) 7. Having taken any medications (including traditional Chinese herbal medicines and dietary supplements) for any reason within 2 weeks prior to study drug administration. (Medical interview) 8. Having used any drugs that may interfere with the absorption or metabolism of the study drug (including hepatic enzyme inhibitors, inducers, or agents altering gastrointestinal environment) or have potential drug-drug interactions with the study drug (e.g., probenecid, P-glycoprotein inhibitors [e.g., itraconazole], or laxatives, antacids, or oral supplements containing high-valence cations [e.g., calcium, iron, magnesium, selenium, or zinc]) within 30 days prior to study drug administration; or planning to use such drugs during the study period, and being deemed unsuitable for trial participation by the investigator. (Medical interview) 9. Having received any vaccine or live-attenuated vaccine within 14 days prior to study drug administration; or planning to receive any vaccine during the trial period. (Medical interview) 10. Having donated blood or experienced massive blood loss (> 400 mL, excluding menstrual bleeding in females) within 3 months prior to study drug administration; or planning to donate blood or blood components during the trial period or within 3 months after trial completion. (Medical interview + network-based screening) 11. Being a substance abuser; or having a history of using soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine) within 1 year prior to study drug administration. (Medical interview) 12. Being a regular smoker; or having smoked more than 5 cigarettes per day within 3 months prior to study drug administrat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood drug concentration - Area under the time curve;Maximum blood drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time;Terminal elimination rate constant;Drug half-life; | — |
Countries
China
Contacts
Public ContactTan Qinyou
The First Affiliated Hospital of Guilin Medical University
Outcome results
None listed