Prevention of acute rejection in adult patients receiving allogeneic kidney transplantation
Conditions
Interventions
Group A:In the fasting state, taking the test formulation in first period and then taking the reference formulation in second period, and taking the test formulation in third period and then taking th
Group B:In the fasting state, taking the reference formulation in first period and then taking the test formulation in second period, and taking the reference formulation in third period and then taki
Group C:In the fed state, taking the test formulation in first period and then taking the reference formulation in second period, and taking the test formulation in third period and then taking the re
Group D:In the fed state, taking the reference formulation in first period and then taking the test formulation in second period, and taking the reference formulation in third period and then taking t
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) The subjects must have informed consent to the experiment, fully understand the content, process, and potential adverse reactions before the experiment, and voluntarily sign a written informed consent form; 2) The subjects are able to communicate well with the researchers and complete the experiment according to the protocol requirements; 3) Gender: only male; 4) Age: 18-55 years old (including 18 and 55 years old); 5) BMI: weight = 50.0kg, 18.6 kg/m2 = BMI = 26.0 kg/m2 (including 18.6 and 22.6 kg/m2).
Exclusion criteria
Exclusion criteria: 1) Those who have participated in any other drug clinical trial and taken the experimental drug within 3 months before the trial; 2) The following diseases with clinical significance in the past (including but not limited to respiratory system, circulatory system, cardiovascular system, digestive system, blood system, endocrine system, immune system, skin system, mental nervous system, facial features, and other related diseases), and have been determined by the research doctor to still have clinical significance; 3) Known severe allergies (such as allergies to 2 or more allergens, allergic asthma affecting the lower respiratory tract, allergies requiring glucocorticoid treatment), or known allergies to mycophenolate sodium or/or any of its components (anhydrous lactose, cross-linked polyvinylketone, polyvinylketone K30, hydroxypropylmethylcellulose phthalate, etc.); 4) Individuals with a history of renal insufficiency, any unstable or recurrent diseases, or intestinal diseases that affect drug administration, absorption, or metabolism; 5) Lactose intolerant individuals (those who have experienced diarrhea due to drinking milk); 6) Individuals with any disease that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, as well as those with active pathological bleeding or a history of intracranial hemorrhage; 7) Individuals with a history of needle/blood fainting or venous puncture intolerance in the past; 8) Individuals who have undergone surgery within 6 months prior to the trial that has been determined by the researcher to affect drug absorption, distribution, metabolism, and excretion, or who plan to undergo surgery during the study period; 9) Regular drinkers within the first 6 months of the experiment, i.e. those who drink more than 14 units of alcohol per week (1 unit=360mL of 5% alcohol beer, 45mL of 40% alcohol spirits, or 150mL of 12% alcohol wine), or those who do not agree to discontinue alcohol intake during the experiment; 10) Those who have used soft drugs (such as marijuana) within 3 months before the experiment or have used hard drugs (such as morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinoid acid) within 1 year before the experiment; 11) Those who smoke more than 5 cigarettes per day within the first 3 months of the experiment, or those who cannot give up smoking or use any tobacco products during the entire hospitalization period; 12) Those who have been vaccinated within 2 weeks before the trial or those who have been vaccinated during the planned trial period and within 4 weeks after the end of the trial; 13) Those who have used any medication (including any prescription drugs, over-the-counter drugs, Chinese herbal medicines, vitamins, health products) within 2 weeks before the experiment, but have reached the drug cleaning time according to the judgment of the researcher, except for those who have not interfered with the experiment; 14) Those who have used any drugs that inhibit or induce liver drug metabolism within 28 days prior to screening (including inducers - barbiturates, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines); 15) Those who have used any drugs that may have drug interactions with mycophenolate sodium within 28 days prior to screening (including azathioprine,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactHan Yangyun; Fan Lian-Lian
Deyang People's Hospital
Outcome results
None listed