The tolerability and pharmacokinetics of Qiangxin Fumai Granules on chinese healthy subjects
- Conditions
- bradyrhythmia
- Registration Number
- ITMCTR1900002406
- Lead Sponsor
- Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Healthy subjects aged 18 to 50 years old, male and female equally.
2. Body mass index (BMI= weight/height 2) was between 19.0 and 25.0 (including the boundary value), and the weight of males was =50kg and females was =45kg.
3. Physical examination found no positive signs;
4. Have the ability to communicate with health care staff and comply with hospital regulations, understand and comply with research requirements;
5. Informed consent, volunteer subjects.
1. Abnormal laboratory examination, imaging examination, electrocardiogram examination and physical examination with clinical significance;
2. A heavy smoker or alcoholic;
3. Substance abuser;
4. Participants who had participated in other clinical trials within three months prior to the trial and had been screened and enrolled;
5. Have used drugs known to cause damage to a certain organ or are currently using drugs within three months prior to the trial;
6. Those who donated blood or lost more than 400 ml of blood within three months before the test;
7. Any history of serious clinical diseases, such as respiratory system, circulatory system, digestive system, urogenital system, blood system, metabolic and endocrine system, motor system, neuropsychiatric system, musculoskeletal system, etc.;
8. Have a history of drug allergy or allergic constitution, and have allergies to the drug ingredients in the study;
9. Patients with medical history of heart, liver, kidney, digestive tract, breast, reproductive system (ovary, testis, epididymis, uterus) and neuropsychiatric system;
10. Immunological examination was positive;
11. Women who are pregnant or breast-feeding; Or have planned to have a family within the last six months or do not intend to take effective measures to prevent pregnancy during the study period;
12. Positive alcohol breath test (=5mg/100ml);
13. People who have used any food that affects the activity of liver medicine enzymes, or have used various drugs and health care products (including traditional Chinese medicine, self-made medicine wine, etc.) within 14 days before the test;
14. Symptoms: fever, heat aversion to cold, thirst, red face, restless, phlegm yellow and thick, short yellow urine, dry stool, red tongue and less fluid, moss yellow dryness, pulse number and other heat syndrome manifestations, referring to the above symptoms, by two senior title of Chinese doctors at the same time to determine, in line with the diagnostic criteria of TCM heat syndrome.
15. The investigator judged that the participants were not suitable for the clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax;ECG test;urine routine test;Cmax,ss;blood biochemistry test;24h DCG;Cmin,ss;AUC0-t;Cav,ss;blood routine test;AUCss;vital signs;stool routine test;
- Secondary Outcome Measures
Name Time Method CL;Tmax;T1/2;Residual area Ratio;?z;AUC0-t/AUC0-inf Ratio;Vd;Tmax,ss;