Single-dose, Open, Randomized, Two-period, Crossover Comparative Bioavailability Study of Sanchi-Tongshu Capsule and Sanchi-Tongshu Capsule (Enteric Coated Pellets) in Chinese Healthy Adult Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
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).
Intervention: Sanchi-Tongshu Capsule (Enteric coated pellets) (Drug)
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).
Intervention: Sanchi-Tongshu Capsule (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h)
Time Frame: Up to 33 hours post dose
Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞)
Time Frame: Up to 33 hours post dose
Maximum observed concentration (Cmax )
Time Frame: Up to 33 hours post dose
Secondary Outcomes
No secondary outcomes reported