None listed
Conditions
Interventions
R1R2:Subjects were dosed in the order of R1-R2 in the fasting state, and the washout time between the two doses was 7 days.
R2R1:Subjects were dosed in the order of R2-R1 in the fasting state, and the washout time between the two doses was 7 days.
Sponsors
Taizhou Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged 18 to 45 (inclusive of 18 and 45); 2. The weight of male subjects should not be less than 50.0 kg, and that of female subjects should not be less than 45.0 kg. Body mass index (BMI) range: 19.0-26.0 kg/m^2 [BMI= Weight (kg)/Height (m)^2] (including 19.0 and 26.0); 3. Have the ability to communicate normally with researchers/medical staff and abide by the relevant management regulations of the hospital; 4. The subjects fully understand the purpose, nature, methods of the trial and possible adverse reactions, voluntarily become subjects, and sign the informed consent form before the start of any research procedure; 5. The subjects must agree to use non-medicine contraception within 14 days before screening and during the trial, and avoid pregnancy or causing a partner to become pregnant or donating sperm or eggs within 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of any serious clinical diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and metabolic abnormalities, or any other diseases or physiological conditions that can interfere with the test results, and have been determined by the researcher as unsuitable to participate in the trial; 2. If any one of the physical examination, vital sign examination, electrocardiogram or laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, serological test, serum pregnancy test (only for female subjects)) is determined by the researcher to be abnormal and of clinical significance; 3. Those with dysphagia, or a history of any gastrointestinal diseases that affect drug absorption, or a history of digestive system surgery (except for appendectomy, hemorrhoid surgery and inguinal hernia repair surgery), or those known to have factors that affect drug pharmacokinetics; 4. Those who have undergone surgery within 6 months prior to the screening, including surgeries that may affect digestion and drug absorption, distribution, metabolism, and excretion, and are considered by the researchers to still have clinical significance at present; Those who plan to undergo surgery during the research period; 5. Those with a history of alcohol abuse or who frequently consumed alcohol within the 6 months prior to screening, that is, men who drank more than 14 units of alcohol per week or women who drank more than 7 units of alcohol per week (1 unit of alcohol is equivalent to 360 milliliters of beer or 150 milliliters of wine or 45 milliliters of 40% distilled spirits, such as Erguotou, etc.) or who could not stop alcohol intake from the date of screening until the end of the trial; 6. Smoking an average of more than 5 cigarettes per day within 3 months prior to screening, or being unable to stop smoking from the date of screening until the end of the trial; 7. Those with a history of drug abuse or who have used drugs within the three months prior to the screening period; 8. Those who have participated in any clinical trials within the 3 months prior to enrollment; 9. Have used any other medications within 30 days prior to screening, including prescription or over-the-counter drugs (including oral multivitamins, herbal medicines, traditional Chinese medicines, medicinal stews or dietary supplements); 10. Those who have consumed foods or beverages such as oranges, grapefruits, pomelos, pomelos, tangerines, pitayas, mangoes, or those containing grapefruit components that affect the absorption, distribution, metabolism, and excretion of the drug within 7 days before screening, or who cannot stop consuming them from the date of screening until the end of the trial; 11. Those who have consumed artichokes or foods or beverages containing artichokes within 7 days prior to screening, or who cannot stop consuming them from the date of screening until the end of the trial; 12. Those who have consumed foods and beverages containing xanthines, caffeine, theophylline, and theobromine (including animal offal, chocolate, tea, coffee, cola, etc.) within two weeks before screening, or who cannot stop consuming them from the date of screening until the end of the trial; 13. Those with a history of clinical drug or food allergies, who are allergic to various components of silymarin, milk thistle fruit or other composi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-8;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;T1/2;kel(?z);AUC_%Extrap;laboratory examination;ECG;Physical examination indicators;Vital signs;Drug combination;Adverse event; | — |
Countries
China
Contacts
Public ContactDongqing Lv
Taizhou Hospital of Zhejiang Province
Outcome results
None listed