A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Sanchi-Tongshu Capsule (Enteric coated pellets)Drug: Sanchi-Tongshu Capsule
- Registration Number
- NCT02316730
- Lead Sponsor
- Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 23
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sanchi-Tongshu Capsule (Enteric coated pellets) Sanchi-Tongshu Capsule (Enteric coated pellets) Sanchi-Tongshu Capsule (Enteric coated pellets) is developed by pharmaceutical factory of Chengdu Huasun Group Inc., 0.35g/capsule, containing 100mg of panaxatriol saponins (PTS). Sanchi-Tongshu Capsule Sanchi-Tongshu Capsule Sanchi-Tongshu Capsule is developed by pharmaceutical factory of Chengdu Huasun Group Inc., 0.2g/capsule, containing 100mg of panaxatriol saponins (PTS).
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West China Second University Hospital
🇨🇳Chengdu, Sichuan, China