Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Dosing sequence 1:The ratio of male to female was 1:1, and the subjects received low dose HL231 inhalation solution (132µg/72µg), control drug, medium dose HL231 inhalation solution (261µg/141µg), and
Dosing sequence 2:The male to female ratio was 1:1, and the subjects were treated with HL231 inhalation solution (261µg/141µg), HL231 inhalation solution (132µg/72µg), HL231 inhalation solution (516µg
Dosing sequence 3:The ratio of male to female was 1:1, and the subjects received HL231 inhalation solution of high dose (516µg/279µg), HL231 inhalation solution of medium dose (261µg/141µg), control d
Dosing sequence 4:The ratio of male to female was 1:1, and the subjects received control drug, high dose HL231 inhalation solution (516µg/279µg), control drug, low dose HL231 inhalation solution (132µ
Sponsors
Research Center for Clinical Trials of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years, both male and female; 2.The weight of male volunteers is >= 50.0 kg, and the weight of female volunteers is >= 45.0 kg, and the body mass index (BMI) is between 19 ~ 26 kg/m2, including cut-off values; 3.Volunteers voluntarily sign written informed consent; 4.After training, the volunteers can correctly grasp the way of inhaling drugs.
Exclusion criteria
Exclusion criteria: 1.Patients who have a history of allergy to indacaterol, grononium bromide or any pharmaceutical excipients, and those who have a known history of allergic diseases or allergic constitution; 2.Congenital galactosemia, glucose and galactose dysabsorbance syndrome, or lactase deficiency in volunteers; 3.Glaucoma, prostatic hypertrophy, urinary retention, or any other condition in which anticholinergic drugs are prohibited in the investigator's opinion; 4.Patients with viral or bacterial infection of upper or lower respiratory tract, sinus or middle ear, and urinary system within 4 weeks prior to screening; 5.Patients who have had or are currently suffering from any clinical serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, urogenital, hematological, immunological, psychiatric and metabolic abnormalities or any other diseases that may interfere with the test results; 6.Have a history of drug, food or other food allergy; 7.Patients who have undergone surgery within 4 weeks prior to the trial, or who plan to undergo surgery during the study period; 8.Patients who have taken any medicine or health care product (including Chinese herbal medicine) within 14 days before the trial; 9.Any drugs that inhibit or induce liver metabolism of drugs (such as inducer-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) were used within 30 days before the trial; Inhibitors -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 10.Participants in any clinical trial and taking any investigational drug within 3 months prior to the trial; 11.Patients who had donated blood or lost a lot of blood (> 200mL, excluding blood loss during menstruation), received blood transfusion or used blood products within 3 months prior to inclusion; 12.Pregnant or lactating women, and volunteers who have an remaining plan or sperm or egg donor within 3 months after the end of the trial period, or who are unable to use one or more non-drug contraceptive methods during and for 3 months after the trial period; 13.Patients who have special requirements on diet and cannot follow the uniform diet; 14.Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250mL) per day; 15.Smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to the experiment or who could not stop using any tobacco products during the experiment; 16.Alcoholics or regular drinkers in the 6 months prior to the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360mL beer or 45mL 40% spirits or 150mL wine) or unable to stop using any alcoholic products during the trial; 17.Drug abusers or those who have used soft drugs (e.g., marijuana) in the last 3 months or hard drugs (e.g., phencyclidine, etc.) in the last 1 year before the trial; 18.Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; Heart rate 100 BPM) or abnormalities in physical examination, electrocardiogram, or laboratory tests are clinically significant (as determined by the clinical investigator); 19.Volunteers who may be unable to complete the study for other reasons or should not be included in the study according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Vital signs;Physical check;Electrocardiogram examination;Laboratory examination;Any spontaneously reported and all directly observed adverse events; | — |
Countries
China
Contacts
Public ContactYang Guoping, Pei Qi
Research Center for Clinical Trials of the Third Xiangya Hospital of Central South University
Outcome results
None listed