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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Sanchi-Tongshu Capsule (Enteric coated pellets)
* Drug: Sanchi-Tongshu Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sanchi-Tongshu Capsule (Enteric coated pellets)<br>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)<br>* Take 0.7g (2 Capsules) of test preparation orally.<br>|
| Active Comparator: Sanchi-Tongshu Capsule<br>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<br>* Take 0.4g (2 Capsules) of reference preparation orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |