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Completed

NCT Number: NCT02316730

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

West China Second University Hospital

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sanchi-Tongshu Capsule (Enteric coated pellets)

Drug

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

Sanchi-Tongshu Capsule

Drug

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

Primary outcomes

  1. Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h)

    Time frame: Up to 33 hours post dose

  2. Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞)

    Time frame: Up to 33 hours post dose

  3. Maximum observed concentration (Cmax )

    Time frame: Up to 33 hours post dose

Sponsors and collaborators

Lead sponsor

Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.

Industry

Collaborators

  • Sichuan University
  • West China Second University Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2014
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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