Bronchial Asthma, Chronic obstructive pulmonary disease
Conditions
Interventions
experimental group:Kudinchoside A Inhalation Solution
Sponsors
The Third Hospital of Changsha
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese health volunteers aged between 18 and 45 (including the threshold), male and female; 2. Male body weight >= 50 kg, female body weight >= 45 kg, and body mass index (BMI) in the range of 19-26 kg/m2 inclusive at screening; 3. Signed the informed consent before the test, and fully understood the content, process and possible adverse reactions of the test; 4. Capable of maintaining good communication with the investigator, and includes compliance with the study requirements and restrictions listed in the consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects Participated in any drug clinical trial within 3 months before using the experimental drug; 2. Subjects have drunk Kuding tea within a week before using the test drug; 3. Subjects with a medical history of respiratory system, digestive system, cardiovascular system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of inherited immune deficiency), metabolic abnormality, etc. and Clinically significant laboratory abnormalities. 4. Allergic to ethanol, Tween, Kudingcha, or foods containing Kudingcha ingredients; or to drugs, foods or other substances; 5. Subjects cannot tolerate venipuncture or faint needles or bleeding; 6. Subjects have received surgery within 6 months before use the drug, and the PI judges will affect the absorption, distribution, metabolism, and excretion; or undergone surgery within 4 weeks; or plan to have a surgery; 7. Subjects who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, health care products, etc.) within 14 days before using the experimental drugs; 8. Use of drug that inhibits or induces liver metabolism within 30 days (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors- SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 9. Vaccinated or attenuated live vaccines within 1 month, or plan to vaccinate during the trial period; 10. Subjects donate blood or lose blood (>400 mL) within 3 months, or received blood transfusion or blood products, or intend to donate blood or blood components during the test period or within 3 months after the end of the test; 11. Drug abusers or used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial; 12. Current smokers(>=5 cigarettes per day) or those who have smoked or used nicotine products within the 3 months prior to screening, or cannot stop using any tobacco products during the period; 13. Alcoholics or drinking alcohol within 6 months before the trail which drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcoholic spirits or 150 mL of wine); Or those who are unwilling to stop drinking or any alcohol-containing products during the trial; 14. Drinking excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup=250 mL) every day, or not agree to stop drinking tea, coffee and/or caffeinated beverages during the period; 15. Subjects eat a diet that may affect the metabolism of the drug in the body before 7 days (including grapefruit or grapefruit products, dragon fruit, mango, grapefruit, orange, etc.), or PI judges that the diet affects drug absorption, distribution, metabolism, and excretion, or Subjects do not agree to stop eating the above diets during the trial; 16. Having a special requirements for diet or cannot follow a unified diet; 17. Volunteers (or their partners) have pregnancy plans, sperm and egg donation plans during the trial period to 6 months after the end of the trial, or are unwilling to take one or more non-drug contraceptive measures (such as total abstinence, Condoms, contraceptive rings, partner ligation, etc.); 18. Female volunteers are pregnant or lactating women; or have unprotected sex within 2 weeks or using oral contraceptives within 30 days or usei
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Vital signs;Laboratory examination; | — |
Countries
China
Contacts
Public ContactLi Huan
Shanghai KE Pharmaceutical Co. Ltd.
Outcome results
None listed