general population
Conditions
Interventions
2:Pidotimod granules (800 mg
trade name: AXIL) produced by POLICHEM S.R.L.
1:Pidotimod tablets (400 mg) provided by Sun Shi (Tangshan) Pharmaceutical Co., Ltd.
Sponsors
Clinical Pharmacological Research Center of Changsha Carnation Geriatric Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 45 years old men and women. Female subjects should be non-pregnant and non-lactating women; 2) Weight: Male is greater than or equal to 50 kg, female is greater than or equal to 45 kg, subject's body mass index (BMI) is between 18.6 and 26.4 kg/m2 (BMI = weight (kg)/height 2 (m2), including the boundary value; 3) Subjects voluntarily sign the informed consent approved by the Ethics Committee; 4) Subjects were able to communicate well with the researchers and agreed to complete the experiment in accordance with the program.
Exclusion criteria
Exclusion criteria: General exclusion criteria: (1) Those who have two or more allergens or who are known to be allergic to Pidotimod tablets or their similar preparations; 2) Patients with gastrointestinal spasm, gastrointestinal ulcer, urinary tract obstruction, mechanical intestinal obstruction, ureteral spasm, biliary tract diseases, liver diseases or other gastrointestinal and liver and kidney diseases affecting drug absorption or metabolism; (3) Those with a history of any serious clinical disease, such as circulatory system, endocrine system, nervous system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or those with a history of malignant tumors, or those with any other diseases or physiological conditions that can interfere with the test results; 4) Any drugs (including Chinese herbs, vitamins, health products) or any drugs (such as inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole) that inhibit or induce drug metabolism were used in the first two weeks of screening or in the first 30 days of screening; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole Categories, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.); 5) Those who used soft drugs (e.g. cannabis) or hard drugs (e.g. morphine, methamphetamine) or positive urine screening results within 3 months before screening or within 1 year before screening; 6) Screening those who had undergone surgery within 6 months or planned to undergo surgery during the study period; 7) Blood donation or other causes of bleeding more than 200 mL in the first three months of screening (except female physiological bleeding); (8) Those who were vaccinated within 3 months before screening; 9) Those who participated in other clinical trials within 3 months before screening; 10) The screening period was evaluated as difficult to collect blood (such as poor blood vessel condition, fear of collecting blood, fainting needle, etc.). 11) Smokers or those who smoke more than 5 cigarettes a day on average or who do not agree to avoid using any tobacco products during hospitalization; 12) alcoholics or those who drink more than 14 units of alcohol per week (1 unit = 360 mL alcohol content of 5% beer or 44 mL alcohol content of 40% spirits or 150 mL alcohol content of 12% wine); 13) Those who drink more than 8 cups of tea, coffee and/or caffeinated drinks a day (1 cup = 250 mL) or who do not agree to prohibit coffee and/or caffeinated drinks during hospitalization; 14) Those who disagree with the screening should avoid eating grapefruit or products containing grapefruit from the same day to the end of the experiment; 15) Those with clinical significance (based on doctor's judgment) who underwent comprehensive physical examination, vital signs examination, electrocardiogram examination and laboratory examination during screening, including four abnormalities of blood routine, urine routine, blood biochemistry and infectious diseases; 16) Within the first four weeks of screening, significant abnormal diets (such as diet and low sodium) or those with special dietary requirements who can not comply with the unified diet have been started. 17) those with dysphagia; 18) Family planning within the past three months; 19) Within six months after signing the informed consent, the subjects had plans for sperm and eggs donation. 20) Subjects did not agree to use non-drug contraception throu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Routine blood test;routine urine test;Blood biochemistry; | — |
Countries
China
Contacts
Public ContactWenjie Liu
Clinical Pharmacological Research Center of Changsha Carnation Geriatric Hospital
Outcome results
None listed