A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)

Pharmaceutical Factory of Chengdu HuaSun Group

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Sanchi-Tongshu Capsule (Enteric coated pellets); Drug: Sanchi-Tongshu Capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02316730

ChiCTR-TTRCC-13003277 (Other Identifier)

SQTS1212

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

23 participants in 2 patient groups

Sanchi-Tongshu Capsule (Enteric coated pellets)

Experimental group

Description:

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).

Treatment:

Drug: Sanchi-Tongshu Capsule (Enteric coated pellets)

Sanchi-Tongshu Capsule

Active Comparator group

Description:

Sanchi-Tongshu Capsule is developed by pharmaceutical factory of Chengdu Huasun Group Inc., 0.2g/capsule, containing 100mg of panaxatriol saponins (PTS).

Treatment:

Drug: Sanchi-Tongshu Capsule