Asthma
Conditions
Interventions
Elderly Group:healthy elderly subjects
healthy adult group:healthy elderly subjects
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
23 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for Elderly Subjects: 1) Aged = 65 years, body mass index (BMI) between 19 ~ 25kg/m2 (BMI = weight (kg)/ height 2 (m2)), men and women; 2) liver and kidney functions were normal, endogenous creatinine clearance rate in the range of 60-120 mL/min.; 3) HBsAg, HCV-AB, RPR, Anti-HIV were negative; 4) During the 48h before the study to the end of study, agrees to quit tobacco, alcohol, caffeine, fruit drinks; 5) Subjects must be able to read and understand the contents of the informed consent and voluntary sign the ICF. Inclusion criteria for Young Healthy Subjects: 1) aged 18-45 years, body mass index (BMI) between 19 ~ 25kg/m2 (BMI = weight (kg)/height 2 (m2)) (weight matched +/-15% with the elderly subjects), both men and women (sex-matched with elderly subjects); 2) Based on the results of physical examination, medical history, vital signs, ECG and clinical laboratory tests, the researchers believe that the subjects are in good health, mood, liver, kidney, gastrointestinal tract, nervous system, metabolic disorders and other mental disorders; ECG, blood pressure, heart rate, respiratory conditions, and laboratory tests including blood, urine, liver and kidney function and other biochemical tests are normal or have no clinical significance; 3) no history of alcohol or drug abuse during the 48h before to the end of the study, agreed to get rid of tobacco, alcohol, caffeine, juice drinks; 4) Subjects must be able to read and understand the contents of the informed consent and voluntary sign the ICF; 5) be able to communicate well with the investigator and the ability to complete the study in accordance with the study requirements.
Exclusion criteria
Exclusion criteria: Exclusion criteria for Elderly subjects: 1) pregnant women or lactating women; 2) Acute respiratory tract infection within two weeks; 3) severe hypertension (systolic blood pressure> 180mmHg and / or diastolic blood pressure> 110mmHg) in patients with coronary insufficiency, angina, heart failure or arrhythmia, or other patients with severe cardiovascular diseases; 4) Patients with severe hyperthyroidism and diabetes; 5) Combined with the diseases in kidney and hematopoietic system; ALT> 1.5 times normal; Cr> 1.2 times normal; 6) Suffering from moderate to severe anemia (Hb <60g / L), coagulation disorders or thromboembolic disease; 7) 30 days before the start of the study have used the drugs which will affect the liver metabolism , or during the study, combined with other drugs that may affect the drugs'absorption, distribution, metabolism, excretion; 8)long-acting ß2 agonists were used before one week entering the trial or using short-acting ß2 agonists three days before entering the trial; 9) have neuropsychiatric, gastrointestinal, respiratory, endocrine system history of serious diseases one year before the start of the study; 10) participated in clinical trials of other drugs 3 months before; 11) has a history of drug allergy; 12) suffering from other serious diseases that may affect the study results; 13) drug abuse, alcoholism; 14) subjects failed to take effective contraceptive measures fertility (female and male); 15) drinking too much tea, coffee and / or caffeine-containing beverages (more than 8 cups per day); 16) The researchers considered unsuitable for other cases enrolled. Exclusion criteria for Young subjects: 1) who are known or suspected to allergy ß2 agonist drug; 2) alcohol, long-term smoking, drug abusers; 3) participating other drug trials three months before; 4) blood donors three month before; 5) have diseases in chronic cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine system; 6) suffering from anemia, coagulopathy or thromboembolic disease; 7) 30 days before the start of the study have used the drugs which will affect the liver metabolism , or during the study, combined with other drugs that may affect the drugs'absorption, distribution, metabolism, excretion; 8) within 14 days before the study taking any drugs or being applied to prevent or treat other drugs; 9) HCG-positive for women of childbearing age, or plan by the (grant) pregnant person (male and female) within three months after the study; 10) subjects could not be completed because of other reasons; 11) Researchers believe that those who should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trantinterol;1-carbonyl trantintero; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital of Central South University
Outcome results
None listed