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

NCT02316730 | Completed Phase 1

• 2 other identifiers: SQTS1212ChiCTR-TTRCC-13003277
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Sanchi-Tongshu Capsule (Enteric coated pellets)

EXPERIMENTAL

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).

Drug: Sanchi-Tongshu Capsule (Enteric coated pellets)

Sanchi-Tongshu Capsule

ACTIVE COMPARATOR

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

Drug: Sanchi-Tongshu Capsule

Interventions

Sanchi-Tongshu Capsule (Enteric coated pellets) DRUG

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

Sanchi-Tongshu Capsule (Enteric coated pellets)

Sanchi-Tongshu Capsule DRUG

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

Sanchi-Tongshu Capsule

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.: lead
• West China Second University Hospital: collaborator
• Sichuan University: collaborator

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610000, China

Location

Study Officials

• Xihong Li, MD

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 15, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 1, 2015

Record last verified: 2014-11

Locations

CN (1)