Allergic rhinitis, urticaria, skin itching (eczema, dermatitis, prurigo, pruritus)
Conditions
Interventions
Test preparation/Reference preparation:Not applicable
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) men and women aged 18 to 65 years (including 18 and 65 years of age); 2) Male subjects weighing not less than 50 kg, female subjects weighing not less than 45 kg. Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index in the range of 19-26 (including the boundary value); 3) Health status: heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities, medical history, blood pressure, 4) subjects (including male subjects) are willing to plan for the next 6 months without pregnancy and voluntary measures to take effective contraception; 5) Before signing the informed consent test, and test content, process and possible adverse reactions to fully understand; 6) can be completed in accordance with the requirements of the pilot program.
Exclusion criteria
Exclusion criteria: 1) Clinical laboratory tests of clinically significant abnormalities, or other clinically significant clinical manifestations of the following diseases (including but not limited to gastrointestinal, renal, hepatic, nerve, blood, endocrine, tumor, pulmonary, immune, Cerebrovascular disease); 2) ECG abnormalities have clinical significance; 3) hepatitis (including hepatitis B and C), syphilis and AIDS screening positive; 4) Persons who have been screened for alcohol or drug use or who have had a history of drug abuse within the past five years or who have used the drug three months before the test; 5) More than 5 cigarettes smoked daily for 3 months prior to the trial; 6) of the benzene or beibenastatin tablets or their accessories have allergies; 7) Have a history of drug and / or alcohol use (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 1 cup of wine); 8) Blood donation or massive blood loss (> 450 mL) within the first three months of administration of the study drug; 9) Any medication that changed liver enzyme activity was administered 28 days prior to the study drug; 10) Take any prescription, non-prescription, any vitamin product or herbal medicine within 14 days of taking the study drug; 11) Two weeks prior to the test, a special diet (including pitaya, mango, grapefruit, and / or xanthine diet) or severe exercise, or other factors affecting drug absorption, distribution, metabolism, excretion and other factors; 12) Take chocolate, any caffeine-containing, or xanthine-containing food or drink 48 hours before taking the study drug; 13) Take any alcoholic product within 24 hours of taking the study medication; 14) taking the study drug within three months of taking the study medication, or participating in a drug clinical trial; 15) have a history of gastrointestinal disease with dysphagia or any effect of drug absorption; 16) There have been major changes in diet or exercise habits recently; 17) Acute disease occurs during the pre-study screening phase or prior to study medication; 18) suffering from any increase in the risk of bleeding diseases, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 19) with the following inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 20) A female subject is in lactation or serum pregnancy positive during the screening period or during the test; 21) Subjects had a history of asthma or history of seizures; 22) There are other acute or chronic diseases that may affect drug absorption and metabolism; 23) Patients with mental or physical disability; 24) have other effects of drug absorption, distribution, elimination and other factors; 25) According to the researcher's judgment, it is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed