Bronchial Asthma
Conditions
Interventions
Experimental group:Albuterol aerosol inhaler, 100ug/puff under fasting, T2 puffs
Reference:Albuterol aerosol inhaler,100ug/puff under fasting R 2 puffs
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male or female volunteers, aged 18~65 years; 2) BMI that is within 19-26kg/m2, exclusive. (The man and female body weight should be over or equal to 50 kg and 45kg, respectively); 3) Healthy or Non Clinical Significant, according to the medical history, Electrocardiography (ECG), Chest X-ray, clinical laboratory and physical examination as determined by the Principal Investigator/Sub-Investigator; 4) Ability to comprehend and be informed of the nature of the study. Capable of giving written informed consent prior to receiving any study medication; 5) Ability to volunteer for communicate effectively with clinic staff and willing to adhere to all protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects whose Hepatitis B surface antigen and/or HCV antibody test is positive; 2. Subjects whose HIV test is positive; 3. Use of any medication(e.g. prescription /over-the counter/ dietary traditional Chinese herbal medicines) within 14 days prior to first drug administration; 4. Use of any organ damage medicine within 90 days prior to first drug administration; 5. Known history of specific allergy (asthma, rubella, eczematous dermatitis), arrhythmia, bradycardia, hypotention, hypertension, coronary heart disease, history of bronchial and cardiovascular diseases, diabetes, hyperthyroidism, Sympathomimetic hypersensitivity, Parkinson's disease, epilepsy,tremor paralysis, or any other disease or condition that can interfere with the outcome of the test; 6. Which is or has been treated for gastrointestinal problems, cramps, peptic ulcers, urinary tract obstruction, mechanical bowel obstruction, ureteral spasm, biliary tract disorders, depression or liver disease; 7. Known presence of Gastrointestinal, liver, kidney disease to interfere with the absorption, distribution, metabolism or excretion of the drug within 6 months prior to first drug administration; 8. Known severe bleeding factors that can affect venous blood collection; 9. Which is suffering from blood coagulation disorders and other diseases of the blood system; 10. Presence of Mental illness past or current history; 11. Known history of cancer; 12. Presence of important organs have primary diseases; 13. Known of undergone surgery within 6 months before the test; 14. Regular drinkers who drink more than 14 units (1 unit = 17.7 mL of ethanol, ie .unit = 357 mL of alcohol with 5% of beer or 44 mL of alcohol at 40% Spirits or 147 mL of wine with a 12% alcohol content) of alcohol per week within 6months before test, alcohol consumption within 48 hours prior to enrollment, or alcohol breath test during screening, or alcohol intake during the study period; 15. Smokers, or those with a history of smoking> 1 year; 16. Presence history of drug abuse within one year prior to the first drug administration (cannabis, cocaine, benzodiazepines, amphetamines, barbiturates) or positive; 17. Drink too much tea, coffee and / or caffeinated beverages (8 cups or more) daily for 48 hours before first drug administration or do not agree that the first cycle should not be consumed daily until the second cycle Tea, coffee and For the first cycle, grapefruit or grapefruit products are not consumed within 48 hours prior to administration or do not agree that the first cycle is administered until the second cycle. Daily consumption of grapefruit or grapefruit products on the 4th day after treatment is prohibited; 19. Subjects or their spouses do not agree to take one or more of the following contraceptives within 6 months of enrollment into the second cycle of medication: condoms, IUDs, IUDs, ligation, abstinence and etc.; 20. Female subject who is enrolled in a pregnancy until 6 months after the end of the study or a male subject who is enrolled in the group until the spouse becomes pregnant within 6 months after the end of the trial; 21. Subject with allergies, including those known to have a history of allergies to salbutamol sulfate or similar drugs or related excipients (e.g., beta 2 agonists, alcohol, and freon); 22. Subject which donate blood or take any investigational drug or participate in any clinical trial within 90 days prior to the first cycle, or plan to donate blood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-inf;AUC0-t; | — |
Countries
China
Contacts
Public ContactYimin Cui
Peking University First Hospital
Outcome results
None listed