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

NCT ID: NCT02316730

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Sanchi-Tongshu Capsule (Enteric coated pellets)

Intervention Type: DRUG

Take 0.7g (2 Capsules) of test preparation orally.

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).

Group Type: ACTIVE_COMPARATOR

Sanchi-Tongshu Capsule

Intervention Type: DRUG

Take 0.4g (2 Capsules) of reference preparation orally.

Interventions

Sanchi-Tongshu Capsule (Enteric coated pellets)

Take 0.7g (2 Capsules) of test preparation orally.

Intervention Type: DRUG

Sanchi-Tongshu Capsule

Take 0.4g (2 Capsules) of reference preparation orally.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

West China Second University Hospital

OTHER

Sponsor Role: collaborator

Sichuan University

OTHER

Sponsor Role: collaborator

Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xihong Li, MD

Role: PRINCIPAL_INVESTIGATOR

West China Second University Hospital

Locations

West China Second University Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

ChiCTR-TTRCC-13003277

Identifier Type: OTHER

Identifier Source: secondary_id

SQTS1212

Identifier Type: -

Identifier Source: org_study_id