Allergic rhinitis Urticaria Itching accompanied by skin diseases (eczema, dermatitis, pruritus)
Conditions
Interventions
GROUP R-T:In the first cycle, the subjects took the reference formulation (R) 20mg (1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 20mg (1 tablet) orally
GROUP T-R:In the first cycle, the subjects took the test formulation (T) 20mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 20mg (1 tablet) orally
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.The subjects fully understood the research purpose, nature, methods and possible adverse reactions, voluntarily became subjects, and signed the informed consent form by themselves before the start of any research procedure; 2.Healthy male or female subjects aged 18 to 45 years old (inclusive); 3.Male weight >=50kg, female weight >=45kg; Body mass Index (BMI) within the range of 19.0 to 26.0kg/m^2 (including the critical value); 4.Vital sign examination, physical examination, clinical laboratory tests (blood routine test, urine dry chemistry + urine sediment quantitative test, blood biochemical test, four blood transfusion tests, four coagulation tests, etc.), 12-lead electrocardiogram examination, etc., those whose results show normal or abnormal but have no clinical significance; 5.All fertile subjects (including the partners of male subjects) had no fertility plans from the signing of the informed consent form to within 3 months after the end of the trial, voluntarily took appropriate and effective contraceptive measures, and had no plans for sperm or egg donation; 6.Those who can communicate well with researchers and understand and comply with all the requirements of this study.
Exclusion criteria
Exclusion criteria: 1.Those who are known to be allergic to any drug, food, etc., or are known to be allergic to the excipients in contrast lastin or its preparations, or have a history of specific allergic reactions (such as asthma, rubella, eczematous dermatitis), or have a severe allergic constitution, and have been determined by researchers to have clinical significance; 2.There is a history of dysphagia or gastrointestinal diseases that affect drug absorption, such as having undergone any surgical procedures that may affect drug absorption, such as gastrectomy or small intestinal resection, cholecystectomy, etc; 3.There is a history of chronic or serious diseases such as the circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic disorders, or any other diseases that may interfere with the test results, as determined by the research doctor to be clinically significant, or a surgical history within 3 months; 4.A history of QT prolongation and/or torsional ventricular tachycardia at the tip (including a history of congenital long QT syndrome); 5.Those with a history of oral diseases such as dry mouth, abnormal salivary secretion, and oral ulcers; 6.Those with a creatinine clearance rate of less than 80mL/min and judged as clinically significant by clinicians; 7.Have used any drugs that have potential interactions with bilastin within 30 days before screening [such as: OATP1A2 substrates or inhibitors (such as ritonavir, rifampicin), P-gp inhibitors or inducers (such as ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazepine or rifampicin, phenobarbital, dexamethasone) (see Protocol Section 1.2.8); 8.Those with poor conditions for vascular puncture, or those who cannot tolerate venipuncture, or those with a history of fainting from needles or blood; 9.Those who have a history of drug abuse within 6 months before screening, or those who have used drugs within 3 months before screening, including repeated and large-scale use of various narcotic drugs and psychotropic substances for non-medical purposes, Or those whose screening tests for any one or more of the urine addiction drugs such as morphine, methamphetamine (methamphetamine), ketamine, dimethylenedioxyamphetamine (ecstasy), and tetrahydrocannabinic acid (cannabis) are positive; 10.Those who have participated in or are currently participating in other drug clinical trials within the three months prior to the screening; 11.Those who have donated blood within 3 months before screening, including component blood or significant blood loss (=400mL), received blood transfusion or used blood products; Or those who plan to donate blood (including blood components) during the trial or within 3 months after the end of the trial; 12.Women who are in the pregnancy or lactation period, or who have had unprotected sex or positive blood pregnancy test results within 14 days before the planned administration of the drug; 13.Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and vitamins within 14 days before screening; 14.Those who have received vaccination within the three months prior to screening, or those who plan to receive vaccination during the trial; 15.Those who smoked more than 5 cigarettes per day within 3 months before screening, or were unable to stop using any tobacco products during the trial period; 16.Those who consumed an average of more than 2 units of alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed