Psoriasis
Conditions
Interventions
Group A:Fasting state before taking the test formulation and after taking the reference formulation
Group B:Fasting state before taking the reference formulation and after taking the test formulation
Group C:The postprandial state was preceded by administration of the test formulation and followed by administration of the reference formulation
Group D:The postprandial state was preceded by administration of the reference preparation and followed by administration of the test preparation
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age and gender: over 18 years old (including 18 years old),both men and women. 2) BMI: male weight = 50.0kg, female weight = 45.0kg, 19.0 kg/m2 = BMI = 26.0 kg/m2. 3) Have a full understanding of the test content, test drug, test process, etc., be able to communicate well with the researcher, complete the study according to the research regulations, and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Those who have participated in any clinical trial and taken medicine within 90 days before the first administration of the trial, excluding those who have not taken medication. 2) Those who have a history of major diseases such as cardiovascular, hepatobiliary, kidney, endocrine, digestive tract, blood system, respiratory system, immune system, mental disorders, metabolic disorders and benign/malignant tumors, or those who have the above diseases, or who are considered by the existing researchers to be not suitable for clinical trials. 3) Those who have a history of suicidal tendencies or behaviors, or depression. 4) People with severe allergic history, allergic constitution or known allergy to the components and excipients of this drug. 5) Difficulty in venous blood collection and/or inability to tolerate venous puncture/indwelling needle or history of needle syncope. 6) Those who have undergone major surgery within six months before the trial screening, or who have undergone surgery that may significantly affect the internal process or safety evaluation of the study drug, or who plan to undergo surgery during the trial screening. 7) Those who donate/lose blood (except for female physiological blood loss) in a large amount (more than 400mL) within 90 days before the first administration of the test, or receive blood transfusion or use blood products, or plan to donate blood or blood components during the test and within 1 month after the last administration. 8) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine and health care products for various reasons within 14 days before the first administration of the test, or who plan to use the above drugs and health care products during the test. 9) Any drugs that inhibit or induce liver CYP3A4 metabolism were used within 28 days prior to administration of the study drug;10) Those who have been vaccinated within 7 days before the first administration of the test, or who plan to be vaccinated during the test. 11) Have a history of drug abuse or drug dependence in the past. 12) Those with positive results in the joint detection of alcohol, breath and urine before drug administration. 13) Previous smokers or those who smoked more than 5 cigarettes per day on average in the three months before screening, or who could not stop using any tobacco products (including nicotine products) during the whole test period. 14) Previous alcoholics/alcoholics, or regular drinkers within 6 months before screening, that is, those who drink more than 14 standard units of alcohol per week, or are unwilling to stop drinking or consuming any alcoholic products during the whole trial period. 15) Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages on average every day within 30 days before the first administration of the test, or those who were unwilling to stop consuming the above beverages during the whole test period. 16) Eating foods that may affect the metabolism of the drug within 14 days before the first administration of the test, or eating other foods that the researcher believes may affect the absorption, distribution, metabolism and excretion of the drug, or unwilling to stop eating the above foods during the whole test period. 17) Lactose intolerance, dysphagia or inability to follow a unified diet. 18) Pregnant or lactating women; Female subjects of childbearing age had unprotected sex within 14 days before the first administration;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactMai Gang,Fan Lian-Lian
Deyang People's Hospital
Outcome results
None listed