Clinical trial NCT02316730: A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: West China Second University Hospital
name: Sichuan University
First posted: 2014-12-15
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h)
timeFrame: Up to 33 hours post dose
measure: Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞)
timeFrame: Up to 33 hours post dose
measure: Maximum observed concentration (Cmax )
timeFrame: Up to 33 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
Study officials:
affiliation: West China Second University Hospital
name: Xihong Li, MD
role: PRINCIPAL_INVESTIGATOR
References: