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

NCT02316730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-05-01

No results posted yet for this study

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

Interventions

DRUG

Sanchi-Tongshu Capsule (Enteric coated pellets)

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

DRUG

Sanchi-Tongshu Capsule

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

Sponsors & Collaborators

  • West China Second University Hospital

    collaborator OTHER

  • Sichuan University

    collaborator OTHER

  • Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xihong Li, MD · West China Second University Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316730 on ClinicalTrials.gov