None
Conditions
Interventions
Postprandial R-T Group:Take the test preparation or reference preparation drug after a high-fat meal
Fasting T-R group:Take the test preparation or reference preparation drug
Fasting R-T group:Take the test preparation or reference preparation drug
Postprandial T-R Group:Take the test preparation or reference preparation drug after a high-fat meal
Sponsors
Huzhou Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Participants must be 18 years of age or older (inclusive), and both males and females are eligible. 2.Male participants must have a body weight of >=50.0 kg, while female participants must have a body weight of >=45.0 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive of boundary values). 3.Participants and their partners must not have any pregnancy plans during the trial period and for three months after the study, and they must voluntarily take effective contraceptive measures (such as complete abstinence, condoms, sterilization, etc.). 4.Participants must be fully informed about the trial's content, process, and potential adverse reactions prior to the trial and must sign an informed consent form, voluntarily agreeing to participate; the informed consent process must comply with GCP. 5.Participants must be able to communicate effectively with the researchers and understand and comply with all the requirements of this study.
Exclusion criteria
Exclusion criteria: 1.Abnormal findings with clinical significance as determined by the investigator in vital signs, physical examinations, complete blood bcounts,lood biochemistry, coagulation tests, urinalysis, 12-lead electrocardiograms, female blood pregnancy tests, and infectious disease screening checks. 2.Individuals with a history of chronic diseases or serious illnesses related to the cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, nervous, gastrointestinal, and respiratory systems, or those in poor overall health. 3.Individuals with a history of mental illness, drug abuse, or drug dependence. 4.Individuals with a history of allergies to tetracycline-class medications such as doxycycline, tetracycline, minocycline, or their excipients, or those with a history of allergies to other drugs, foods, or environmental factors, totaling two or more. 5.Individuals who, within the three months prior to screening, consumed an average of more than 14 standard units of alcohol per week (one standard unit contains 14 g of alcohol, such as 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine); or those who do not agree to abstain from alcohol from the screening date until the end of the trial. 6.Individuals who, within the three months prior to screening, had an average daily smoking quantity of =5 cigarettes, or those who do not agree to abstain from smoking from the screening date until the end of the trial. 7.Individuals who have a history of blood donation in the three months prior to screening or have experienced significant bleeding (>400 mL) (excluding women’s menstrual periods). 8.Individuals who have undergone surgery in the three months prior to screening or during the screening period, or who have had surgery that affects the absorption, distribution, metabolism, or excretion of drugs, or who plan to undergo surgery during the study. 9.Individuals who have consumed an excessive amount of tea, coffee, or caffeinated beverages (more than 8 cups per day, with one cup equaling 250 mL) in the three months prior to screening; or who have ingested any caffeinated food or drink (such as coffee, tea, chocolate, etc.) within 48 hours prior to administration. 10.Individuals who participated as subjects in other interventional clinical trials in the three months prior to screening. 11.Individuals who have received vaccinations within one month prior to screening or who plan to be vaccinated during the trial. 12.Individuals who have consumed large amounts of grapefruit or grapefruit-containing foods or beverages (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days prior to screening; or who have ingested foods or beverages high in caffeine or theobromine (such as chocolate, coffee, strong tea, cola, etc.) within 48 hours prior to admission and during the hospitalization, or who have consumed grapefruit, dragon fruit, mango, lime, star fruit, or foods or beverages made from them that could impact drug absorption, distribution, metabolism, or excretion. 13.Individuals who have used any prescription medications, over-the-counter drugs, or herbal medicines within 14 days prior to screening. 14.Individuals who tested positive for substance abuse on the day of admission (including morphine, delta-9-tetrahydrocannabinol, methamphetamine, desomorphine, ketamine, or cocaine); or those who tested positive for alcohol on a breathalyser test conducted on the day of admission. 15.Individuals with specific dietary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z;Tmax;AUC_%Extrap;t1/2; | — |
Countries
China
Contacts
Public ContactChen Yingrong
Huzhou Center Hospital
Outcome results
None listed