Healthy Volunteers
Conditions
Interventions
Group A:Sanqi extract, 90 ml, orally taken. Three days after the single dose,male subjects in this group orally taken 90 ml sanqi extract once daily for 21 days. Plasma and urinary drug concentration
Group B:Sanqi extract, 180 ml, orally taken.Plasma and urinary drug concentration were monitored within three days after oral dose
Group C:Sanqi extract, 270 ml, orally taken. plasma at 0, 0.5, 1.5, 3, 4.5, 8, 12, 15, 24, 30, 38, 48, 56 h and urine at 0-3, 3-6, 6-10, 10-14, 14-24, 24-32, 32-40,40-48, 48-72 h postdose were collect
Sponsors
Shanghai Institute of Materia Medica, Chinese Academy of Science; Tianjin University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Healthy human subjects between 18 to 35 years old with body mass index not exceeding the ideal value more than 15%; 2. Subjects who understand the purpose, character, procedures of the pharmacokinetic study, as well as the characteristics of Sanqi extract. Subject signed Informed Consent Form prior to this study.
Exclusion criteria
Exclusion criteria: 1. Subjects who took any over-the-counter or prescription drugs within two weeks or any Asian ginseng, American ginseng, or Sanqi-related drug, food, health-care product, medicated diet within one week; 2. Subjects allergic to Asian ginseng, American ginseng, or Sanqi gradient or product; 3. Subjects who participated any investigational drug study within 1 months prior to this study; 4. Menstrual, pregnant or lactating women and women at childbearing age take oral contraceptive; 5. In the opinion of the investigator, subjects who are not suitable to participate in the study for whatever reasons must be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma;Drug concentration in urine; | — |
Countries
China
Contacts
Public ContactChuan Li
Outcome results
None listed