chronic obstructive pulmonary disease
Conditions
Interventions
Group A:T1-R-T2-R
Group B:R-T1-R-T2
Group C:T2-R-T1-R
Group D:R-T2-R-T1
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Health male and female, and the selected subjects should have an appropriate gender ratio; 2.Aged 18-65 years(including boundary value); 3.The body weight of male >= 50.0kg, female >= 45.0kg, body mass index (BMI) between 19.0 and 26.0kg/m2 (including boundary value); 4.Subjects must give informed consent to the study prior to the trial and voluntarily sign written informed consent; 5.The subjects can communicate well with the investigator, use the aerosol device correctly after training, and complete the research according to the research regulations.
Exclusion criteria
Exclusion criteria: 1.Those who are allergic to any component of budesonide and formoterol fumarate dihydrate inhalation aerosol and its related compounds and excipients, or who are allergic to two or more drugs (or foods); 2.Those who cannot follow a uniform diet (such as intolerance to standard meals); 3.Can not tolerate venipuncture, there is a history of fainting halo; 4.There are medical history, liver, kidney, endocrine, metabolic, digestive tract, blood system, respiratory system, infection, malignant tumor, mental disorder and other medical history that the researcher judges to have clinical significance or existing diseases; 5.Those who have undergone major surgery within 6 months prior to screening, or who plan to undergo surgery during the study period, and those who have received surgery that affect drug absorption, distribution, metabolism, and excretion (except for appendicitis surgery); 6.Physical examination during screening, vital signs monitoring, ECG, chest CT, pulmonary function test, laboratory test (blood routine, urine routine, blood biochemistry, coagulation function, etc.), the researchers judged abnormal clinical meaning person 7.Hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody or HIV antibody test results are clinically significant; 8.Drinking excessive (8 cups or more per day, 1 cup = 200mL) tea, coffee or caffeinated beverages in the long-term (within 3 months before screening); or ingesting any coffee containing coffee within 48 hours before the first dose For food or beverages (such as coffee, tea, chocolate, etc.); 9.Study any beverages or foods that are rich in jaundice or grapefruit or other substances that affect the absorption, distribution, metabolism, excretion, etc. of the drug within 48 hours before the first dose; 10.Those who have used long-acting estrogen or progesterone injections or implants within 6 months before the test; those who have used short-acting contraceptives within 30 days before the test; 11.Study any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health care products used within 14 days before the first dose; 12.More than 5 cigarettes per day for the first 3 months of screening, or those who are positive for smokers and those who are not allowed to accept smokers after the trial period; 13.Study the positive alcohol test results before the first dose, or drink more than 14 standard units per week for the first 6 months of screening (1 standard unit contains 14g alcohol, such as 360mL beer or 45mL alcohol with 40% spirits or 150mL wine); 14.Study the positive urine drug test before the first dose or the history of drug abuse (such as marijuana, benzodiazepine, ketamine, morphine, cocaine, methamphetamine) within 1 year before the test; 15.pregnant or lactating women or those who have a positive pregnancy test, as well as male subjects (or their partners) or female subjects who have a pregnancy plan throughout the trial period and within 3 months after the end of the study; 16.Studying those who participated in other clinical trials and took the study drug within 3 months prior to the first dose; 17.Study blood donation or blood loss >= 400mL within 3 months before the first dose, or plan to donate blood or blood components during the study period or within 3 months after the end of the study; 18.The investigator judged that the subjects were not suitable to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t, AUC0-8, Cmax, t1/2, ?z, Tmax and AUC_%Extrap;Safety index: Adverse events, Vital signs, Physical examination, ECG, Laboratory examination; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Outcome results
None listed