Clinical study of Xinyang tablet in healthy volunteers under fasting conditio

Phase 1

• Conditions: nothing

• Registration Number: ITMCTR2000003067
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Volunteers fully understand the purpose, nature, method and possible adverse reactions of the trial, volunteer as volunteers, and sign the informed consent before all research procedures;
(2) Healthy male or female volunteers over the age of 18 (including threshold);
(3) The body weight of male >=50.0kg, female >=45.0kg; body mass index (BMI) in the range of 19.0-26.0kg/m2 (including the threshold value);
(4) The volunteers had no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, biliary tract, respiration, blood and lymph, endocrine, immune, mental, neuromuscular, gastrointestinal system, etc. within three years, and were in good general health;
(5) Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, the results show normal or abnormal without clinical significance;
(6) The volunteers (including male volunteers) had no family planning during the experiment and within 6 months after the experiment, and they voluntarily took effective contraceptive measures and had no sperm donation or egg donation plan;
(7) Be able to communicate well with researchers and understand and comply with the requirements of this study.

Exclusion Criteria

1) Allergic constitution, such as those who are known to be allergic to traditional Chinese medicine, seafood and other substances (consultation);
2) Patients with acute disease within two weeks before taking the test drug for the first time (consultation);
3) Those who have received surgery within 6 months before the trial, or who plan to carry out surgery during the study (consultation), which is judged by the researcher to affect drug absorption, distribution, metabolism and excretion;
4) Those who have used any drug (including prescription drug, over-the-counter drug, Chinese herbal medicine) within 2 weeks before taking the test drug for the first time (consultation);
5) 28 days before the test, any drugs that inhibit or induce liver metabolism (such as inducers - barbiturates, carbamazepines, phenytoin, glucocorticoids; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) were used (for consultation);
6) Those who received vaccination within 4 weeks before the trial (consultation);
7) Those who have participated in other clinical trials or used the drugs related to the trial within 3 months before the trial (consultation);
8) There were blood donors within 3 months before the test, and the total amount of blood loss due to blood donation or other reasons within 6 months reached or exceeded 400ml (except for normal blood loss in female physiological period) (consultation);
9) In the past year, there has been a history of alcoholism, that is, drinking more than 14 units of alcohol per week (1 unit = 360ml of beer or 45ml of white spirit or 150ml of wine with 40% alcohol content), or being unable to prohibit alcohol during the test period, or the alcohol breath test result is greater than 0.0mg/100ml (consultation and examination);
10) Those who smoke more than 5 cigarettes per day in 3 months before the test, or who can't stop using any tobacco products during the test (consultation);
11) In the three months before the trial, there was a history of drug abuse (including repeated and large-scale use of all kinds of narcotic drugs and psychotropic substances for non-medical purposes) or drug abuse screening (including: morphine, methamphetamine, ketamine, ecstasy (dimethyldioxygoamphetamine), marijuana (tetrahydrocannabinolic acid), etc.) positive (consultation and examination);
12) Four blood transfusion tests (hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, Treponema pallidum antibody) were positive;
13) Those who can't tolerate venipuncture or have a history of needle syncope and blood stasis (consultation);
14) Lactose intolerance (consultation);
15) Those who have special requirements for diet and cannot accept unified diet (consultation);
16) According to the judgment of the researcher, there is a low possibility of enrollment or poor compliance (such as physical weakness, etc.); in addition to the above requirements, female volunteers who meet the following conditions should also be excluded:
17) Those who used oral contraceptives within 30 days before the trial (consultation);
18) Those who used long-acting estrogen or progestin injection (including progestin IUD) or implant (consultation) within 6 months before the trial;
19) Unprotected sexual behaviors (consultation) occurred with partners within 14 days before the trial;
20) The blood pregnancy and urine pregnancy w

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preliminary establishment of pharmacokinetic parameters;Identification and identification of human body components;Establishment of analytical conditions for biological samples - qualitative analysis;