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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
• Collaborators: Sichuan University; West China Second University Hospital

Criteria

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.