Psoriasis
Conditions
Interventions
Fasting group A (T-R):Take the test preparation first and then take the reference reagent
Fasting group B (R-T):Take the reference reagent first and then take the test preparation
Postprandial group A (T-R):Take the test preparation first and then take the reference reagent
Postprandial group B (R-T):Take the reference reagent first and then take the test preparation
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions; 2. Be able to complete the research in accordance with the requirements of the experimental protocol; 3. Subjects (including male subjects) have taken effective contraceptive measures within 14 days before screening and are willing to have no pregnancy plan within 6 months after the end of the study and voluntarily take effective contraceptive measures; 4. Subjects aged 18 to 50 (including 18 and 50 years old), no gender limit; 5. Male subjects should weigh no less than 50 kg. Female subjects should weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height ^2 (m^2), with a BMI in the range of 18.0-28.0 kg/m^2 (including cutoff values).
Exclusion criteria
Exclusion criteria: 1. Abnormal conditions judged by clinicians to have clinical significance, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination; or have a serious medical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorder and metabolic disorder, and the research doctor thinks it is not suitable for participants; 2. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive; 3. Those with a history of specific allergies or allergies (such as those who are allergic to two or more drugs, foods such as milk and pollen), or those who are known to be allergic to the components or analogs of this drug; 4. Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to taking the study drug (such as CYP3A4 inhibitors - clarithromycin, erythromycin, verapamil, voriconazole, ketoconazole, etc., CYP3A4 inducers - rifampicin, phenytoin, carbamazepine, etc.); 5. Those with a history of depression; 6. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine); 7. Difficulty swallowing or any history of gastrointestinal diseases that affect drug absorption (such as gastric or small bowel resection, atrophic gastritis, gastrointestinal bleeding, obstruction, etc.); 8. Female subjects are breastfeeding or have positive pregnancy test results during the screening period or clinical trial; 9. Subjects with positive drug screening or a history of drug abuse within the past five years or drug use within 3 months prior to taking the drug; 10. Those who smoked more than 5 cigarettes per day on average in the 3 months before the trial; 11. Blood donation or massive blood loss (>400mL) within 3 months before taking the study drug; 12. Have a history of surgery within 3 months before taking the study drug or have taken the study drug or participated in other clinical trials of drugs; 13. Taking any prescription medication within 14 days prior to taking the study drug; 14. Taking any over-the-counter medicines, Chinese herbal medicines or health supplements within 7 days before taking the study drug; 15. Those who have taken special diets (such as grapefruit and products containing grapefruit) or exercised vigorously within 48 hours before taking the study drug, or have other factors that affect drug absorption, distribution, metabolism, and excretion; 16. Consumed chocolate, any food containing caffeine or rich in xanthine (such as animal liver) within 48 hours before taking the study drug; 17. Have taken any alcohol-containing products within 24 hours before taking the study drug, or have a positive alcohol test; 18. Subjects deemed inappropriate by other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak concentration of drug;area under the drug-time curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| peak time of drug action;half life; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed