Broad spectrum antibacterial agent
Conditions
Interventions
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age above 18 years old (including 18 years old), both male and female are eligible; 2. Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index [BMI=weight (kg)/height ^2 (m^2)] should be within the range of 19.0-26.0 kg/m^2 (including boundary values); 3. The subjects and their partners have no pregnancy plans during the trial period and within 3 months after the end of the study, and voluntarily adopt effective contraceptive measures; 4. Before the experiment, fully understand the content, process, and possible adverse reactions of the experiment, sign an informed consent form, and voluntarily participate in the experiment; The process of obtaining informed consent complies with GCP; 5. Able to communicate effectively with researchers and understand and comply with the requirements of this study
Exclusion criteria
Exclusion criteria: 1. Abnormal vital signs, physical examination, blood routine, blood biochemistry, coagulation test, urine routine, 12 lead electrocardiogram, female blood pregnancy, and preoperative four tests determined by researchers to have clinical significance; 2. Individuals with a history of chronic or severe diseases such as cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, neurological, gastrointestinal, and respiratory systems, and overall poor health status; 3. Individuals with a history of mental illness, drug abuse, or drug dependence; 4. Those who have a history of allergies to tetracycline drugs or excipients such as doxycycline, tetracycline, doxycycline, minocycline, or have accumulated two or more allergies to other drugs, food, or the environment in the past; 5. Individuals who have consumed an average of more than 14 standard units of alcohol per week within the first 3 months of screening (1 standard unit contains 14 g of alcohol, such as 360mL of beer or 45mL of 40% alcohol strong liquor or 150mL of wine); Or those who do not agree to abstain from alcohol during the period from the screening date to the end of the experiment; 6. Individuals who have smoked an average of = 5 cigarettes per day within the past 3 months prior to screening, or those who do not agree to smoking bans from the screening date until the end of the trial; 7. Screening for individuals with a history of blood donation or significant bleeding (>400mL) in the previous 3 months (excluding females during their menstrual period); 8. Individuals who have undergone surgery within the 3 months prior to or during the screening period, or who have undergone surgery that affects drug absorption, distribution, metabolism, or excretion, or who plan to undergo surgery during the study period; 9. Screen individuals who have consumed excessive amounts of tea, coffee, or caffeinated beverages (8 or more cups per day, 1 cup=250mL) within the past 3 months; Those who consume any food or beverage containing caffeine (such as coffee, tea, chocolate, etc.) within 48 hours before administration; 10. Screening participants who have participated in other intervention clinical trials as subjects within the previous 3 months; 11. Select individuals who have received the vaccine within the previous month or plan to receive the vaccine during the trial period; 12. Individuals who have consumed a large amount of beverages or foods rich in grapefruit (grapefruit) within the 14 days prior to screening (such as grapefruit, grapefruit juice, grapefruit jam, etc.); Individuals who have consumed foods or beverages rich in caffeine or xanthine (such as chocolate, coffee, strong tea, cola, etc.) within 48 hours prior to check-in and during hospitalization, or who have consumed special diets such as grapefruit, dragon fruit, mango, lime, starfruit, or foods or beverages prepared from them that affect drug absorption, distribution, metabolism, and excretion; 13. Individuals who have used any prescription, over-the-counter, or traditional Chinese medicine within the 14 days prior to screening; 14. Those who tested positive for drug abuse screening (morphine, tetrahydrocannabinol acid, methamphetamine, methylenedioxymethamphetamine, ketamine, cocaine) on the day of check-in; Or those who have a positive alcohol breath test result on the day of check-in; 15. Those who have special dietary requirements and cannot follow a uniform diet; Or those who have difficulty swa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-t;AUC0-8;?z;t1/2; | — |
Countries
China
Contacts
Public ContactChen Yingrong
Huzhou Central Hospital
Outcome results
None listed