healthy volunteers
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy without history of heart, liver, kidney, digestive tract, nervous system, mental disorder and metabolic disorder. 2. Aged between 18 and 65, regardless of gender. 3. The weight (calculated by BMI = weight (kg) / height (M2)) is between 19.0 and 26.0. 4. Informed consent, voluntary test. The process of obtaining informed consent shall be in accordance with GCP.
Exclusion criteria
Exclusion criteria: 1. The physical examination shows that the abnormalities of body temperature, blood pressure, heart rate, respiration, liver, spleen and kidney are of clinical significance; Physical and chemical examination showed abnormal blood routine (WBC, PLT), liver function (alt, AST) and renal function (BUN, Cr). 2. Those with positive symptoms or yin deficiency and Yang excess symptoms, such as irritability, restlessness, dry stool, dry mouth, bad breath, etc. 3. Take any other drugs within two weeks before the test. 4. Used drugs known to damage certain organs within three months. 5. Blood donors within three months. 6. Pregnant and lactating women. 7. Those who cannot give full informed consent due to intellectual or behavioral disorders. 8. Suspected or true history of alcohol and drug abuse. 9. According to the judgment of the researcher, other diseases that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in working environment, are easy to cause loss of follow-up. 10. Allergic constitution, such as a history of allergy to two or more drugs or food; Or known to be allergic to the ingredients of this drug. 11. Patients participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| metabolome; | — |