Healthy people
Conditions
Interventions
Test group:Qipo Shengmai Granules:20g,PO.
Sponsors
Guang'anmen Hospital,China Academy of Traditional Chinese Medicine.
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) I have fully understood and voluntarily signed a written informed consent form for this study, and am able to comply with the requirements and limitations listed in the informed consent form; (2) The age range is between 18 and 45 years old (including the threshold), with a male to female ratio of 1:1; (3) When screening, male weight = 50kg, female weight = 45kg, and body mass index (BMI) between 19-25 kg/m2 (including 19kg/m2 and 25kg/m2; BMI=weight ÷ height 2); (4)During screening, all examinations (including physical examination, vital signs examination, blood routine, urine routine, blood biochemistry, coagulation function, 12 lead electrocardiogram, chest X-ray, ultrasound, etc.) showed no abnormalities or slight abnormalities, but the researchers determined that there was no clinical significance.
Exclusion criteria
Exclusion criteria: (1) I have taken traditional Chinese medicine in the past month; (2) Those who have been determined by researchers to be unsuitable for taking Qiposhengmai granules or those with low compliance; (3) Subjects with a history of gastrointestinal surgery or gastrointestinal diseases that affect drug absorption; (4) Have a history of Drug allergy or atopic allergic disease (asthma, Hives, eczema dermatitis), or known Drug allergy to test drugs or similar test drugs, or allergic constitution or skin test positive; (5) Individuals who have previously suffered from malignant tumor diseases; (6) Individuals who have participated in clinical trials of any drug or medical device within the past 3 months, or those who were within 5 half-lives of the investigational drug before screening (5 half-lives of the investigational drug exceeding 3 months); (7) Those who have experienced severe trauma or undergone surgery within the past 6 months, or plan to undergo surgery during the trial period; (8) Have a history of blood donation within the past 3 months, or have experienced severe blood loss (blood loss = 400mL), or have received a blood transfusion; (9) Individuals who have made significant adjustments to their previous dietary plan within the past month, or who have been unable to maintain a stable dietary intake during the study period, or who are vegetarian; (10) Individuals with a history of infectious diseases such as viral hepatitis, human immunodeficiency virus infection, and syphilis; (11) Patients with primary diseases such as heart, liver, kidney, digestive tract, nerve, Hematology and metabolic abnormalities; (12) Systolic blood pressure140 mmHg, diastolic blood pressure90 mmHg, heart rate100 bpm; (13) Those who are taking other preventive or therapeutic drugs; (14) Individuals with a history of mental illness or physical disability; (15) The average daily smoking volume in the first three months of screening is = 5 cigarettes; (16) Those who drink alcohol within 7 days or have taken alcoholic products within 2 days, or have a history of alcohol abuse; (17) Individuals with a history of drug use or substance abuse; (18) Pregnant or lactating women, or female subjects of childbearing age, tested positive for urinary pregnancy screening; Or if there is a pregnancy plan within 6 months. (19) Subjects who are expected to be unable to complete the entire trial follow-up; (20) The researchers believe that subjects with any other factors that are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum (or peak) serum concentration;AUC0-last;Time to reach Cmax ;Half-life ; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event; | — |
Countries
China
Contacts
Public ContactYuanhui Hu
Guang'anmen Hospital,China Academy of Traditional Chinese Medicine.
Outcome results
None listed