Healthy
Conditions
Brief summary
24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized, crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1 as detection indicators. Establish the blood drug concentration-time curve, compare the bioequivalence of the main effective ingredients of the two preparations during the absorption process in human.
Interventions
DRUGSanchi-Tongshu Capsule (Enteric coated pellets)
Take 0.7g (2 Capsules) of test preparation orally.
DRUGSanchi-Tongshu Capsule
Take 0.4g (2 Capsules) of reference preparation orally.
Sponsors
West China Second University Hospital
Sichuan University
Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* The healthy male volunteers aged 18-40 years old; * The body mass index is within 19-24, and the body weight is not less than 50kg( body mass index=body weight (kg)/height (M)2); * All the examination indicators such as heart, liver, kidney, blood and so on are within normal range; * The subjects should be without the addiction to smoking or alcohol, without drug abuse history and agree not to drink beverages containing caffeine during the trial; * The subjects fully understand the objective, method and content of the trial, as well as the test preparation and reference preparation, and are willing to sign informed consent.
Exclusion criteria
* The subjects that are found to have any significant clinical diseases by direct questioning and comprehensive physical examination and laboratory examination before study; * Allergic constitution, such as the patients with allergy history to two or more food and drugs; or those known to be allergic to the ingredient of the drug. * The individuals with low possibility of enrollment (such as physically weak and so on) according to investigator's judgement; * The patients that have any reasons considered by the investigator to prevent the subjects from finishing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h) | Up to 33 hours post dose |
| Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞) | Up to 33 hours post dose |
| Maximum observed concentration (Cmax ) | Up to 33 hours post dose |
Countries
China
Outcome results
None listed