chronic obstructive pulmonary disease
Conditions
Interventions
experimental group:Radix Rehmanniae oligosaccharides inhalation preparation, inhaled through lung, single dose
Sponsors
Shuguang Hospital affiliated to Shanghai University of TCM
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Healthy men aged 18 to 40 years, weighing no less than 50.0 kg; (2) The body mass index (BMI) (weight (kg) / height (M2)) was in the range of 19.0-26.0 (including the critical value); (3) Health status: no medical history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities; physical examination showed normal temperature, pulse and blood pressure; normality or abnormality of ECG, respiratory system, liver and kidney function, hemogramand urine routine examination had no clinical significance; (4) The informed consent was signed before the trial, and the content, process and possible adverse reactions of the trial were fully understood; (5) Be able to complete the research according to the requirements of the test scheme.
Exclusion criteria
Exclusion criteria: (1) Screening examination results show that there are clinically significant abnormalities, or other clinical findings show the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases); (2) Abnormal ECG has clinical significance; (3) The abnormal results of hepatitis B, hepatitis C, HIV and syphilis have clinical significance; (4) Have a history of drug use or drug abuse; (5) Having taken the clinical study drug within 3 months before taking the study drug or enrolled in the drug clinical trial; (6) More than 5 cigarettes were smoked per day within 3 months before taking the study drug; (7) The total amount of blood donation exceeds 400 ml within 3 months before taking the study drug, or intends to donate blood or blood components during the study period, or loses more than 400 ml blood; (8) Any drug that changes liver enzyme activity was taken 28 days before administration of the study drug; (9) Taking any prescription drug, over-the-counter drug, any vitamin drug or Chinese herbal medicine within 14 days before taking the study drug; (10) Positive results of alcohol breath test or drug test within 24 hours before taking the study drug; (11) Those who could not tolerate venipuncture and had history of needle syncope and blood syncope; (12) Other researchers judged the subjects who were not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to maximum concentration;maximum concentration;half life;Area under curve;Plasma clearance rate; | — |
Countries
China
Contacts
Public ContactLi Liu
Shuguang Hospital affiliated to Shanghai University of TCM
Outcome results
None listed