Antibacterial
Conditions
Interventions
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria in order to be included in this trial: 1) Gender: Male or female; 2) Age: 18 years old or above (including 18 years old); 3) Weight: Male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, and the body mass index [BMI=weight (kg)/height 2 (m2)] should be within the range of 19.0 to 26.0 kg/m2 (including boundary values); 4) Voluntarily participate and sign an informed consent form; The process of obtaining informed consent is in accordance with GCP; 5) Able to communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Subjects with any of the following characteristics cannot be included in this study: 1) Abnormal vital signs, physical examination, blood routine test, blood biochemistry, blood coagulation test, urine routine test, 12 lead ECG, and preoperative four tests, which are judged by the researcher to be clinically significant; 2) Individuals with any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers; 3) Individuals with a history of asthma or seizures; 4) Individuals with a history of intracranial hemorrhage; 5) Individuals with a history of chronic or serious diseases such as liver, kidney, digestive tract, endocrine system, cardiovascular and cerebrovascular system, nervous system, metabolic system, blood system, respiratory system, and autoimmune system, or existing systemic diseases, and those who are determined by the researcher to be unsuitable for enrollment; 6) Individuals with a history of mental illness, drug abuse, or drug dependence; 7) Those who have special dietary requirements and cannot follow a unified diet; Or those with difficulty swallowing; 8) Those who have accumulated two or more allergies to other drugs, food, or the environment; Or those who have previously been allergic to any components of oxazolidinone antibiotics, linezolid, or excipients; 9) Those who have used any drug that interacts with linezolid within 30 days prior to screening; Or those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within the first 14 days of screening; 10) Individuals who have consumed excessive amounts (8 or more cups per day, 1 cup=250 mL) of tea, coffee, or caffeinated beverages within the first 3 months of screening; Or taking tea or any caffeinated food or beverage (such as coffee, chocolate, etc.) within 48 hours before administration; 11) Those who consume a large amount of grapefruit rich beverages or foods (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; Or those who have consumed any beverage or food rich in grapefruit (grapefruit) within 48 hours before administration; 12) Difficulty in blood collection or inability to tolerate venous indwelling needle blood collection; Individuals with a history of needle or blood sickness; 13) Individuals who have consumed an average of more than 14 standard units of alcohol per week (1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening; Or those who do not agree to abstain from alcohol from the screening date until the end of the experiment; 14) Those who smoke an average of 5 cigarettes per day or more in the first 3 months of screening, or those who do not agree to ban smoking from the screening date to the end of the experiment; 15) Individuals who have participated in other clinical trials within the first 3 months of screening; 16) Individuals with a history of blood donation or significant bleeding (>400 mL) within the first 3 months of screening; 17) Those who have undergone surgery within 3 months before screening or during screening, or have undergone surgery that affects absorption, distribution, metabolism and excretion, or plan to perform surgery during the study period; 18) On the day of check-in, those who tested positive for drug abuse screening (morphine, tetrahydrocannabinoid acid, methamphetamine,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Cmax;AUC0-t;AUC0-8;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed