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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sanchi-Tongshu Capsule (Enteric coated pellets); Drug: Sanchi-Tongshu Capsule

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Second University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Drug: Sanchi-Tongshu Capsule (Enteric coated pellets); Take 0.7g (2 Capsules) of test preparation orally.
ACTIVE_COMPARATOR: 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).	Drug: Sanchi-Tongshu Capsule; Take 0.4g (2 Capsules) of reference preparation orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
• Collaborators: West China Second University Hospital; Sichuan University
• Investigators: Principal Investigator: Xihong Li, MD, West China Second University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (ESTIMATE): December 15, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: SQTS1212; ChiCTR-TTRCC-13003277 (OTHER: Chinese Clinical Trial Registry)