HealthyPhase 1NCT02316730
A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)
A Phase 1 study testing Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule in people with Healthy, run by Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Sanchi-Tongshu Capsule (Enteric coated pellets), Sanchi-Tongshu Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanchi-Tongshu Capsule (Enteric coated pellets)Drug
Take 0.7g (2 Capsules) of test preparation orally.
Sanchi-Tongshu CapsuleDrug
Take 0.4g (2 Capsules) of reference preparation orally.
| Study group | Role | What they receive |
|---|---|---|
| Sanchi-Tongshu Capsule (Enteric coated pellets) | Experimental | 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). Receives: Drug: Sanchi-Tongshu Capsule (Enteric coated pellets) |
| Sanchi-Tongshu Capsule | Active comparator | Sanchi-Tongshu Capsule is developed by pharmaceutical factory of Chengdu Huasun Group Inc., 0.2g/capsule, containing 100mg of panaxatriol saponins (PTS). Receives: Drug: Sanchi-Tongshu Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h)
Measured: Up to 33 hours post dose
Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞)
Measured: Up to 33 hours post dose
Maximum observed concentration (Cmax )
Measured: Up to 33 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Second University Hospital, Sichuan University
- Responsible party
- Sponsor
- Investigators
- Xihong Li, MD, Principal investigator, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316730
- Sponsor's protocol ID
- SQTS1212
- Other IDs
- ChiCTR-TTRCC-13003277
- Status last verified
- Nov 2014
- First submitted
- 10 Dec 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02316730
- Acronym / sponsor ID
- SQTS1212
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- West China Second University Hospital, Sichuan University
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanchi-Tongshu Capsule (Enteric coated pellets) | Experimental | Drug: 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). |
| Sanchi-Tongshu Capsule | Active comparator | Drug: Sanchi-Tongshu CapsuleSanchi-Tongshu Capsule is developed by pharmaceutical factory of Chengdu Huasun Group Inc., 0.2g/capsule, containing 100mg of panaxatriol saponins (PTS). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sanchi-Tongshu Capsule (Enteric coated pellets)Take 0.7g (2 Capsules) of test preparation orally. | Drug | Sanchi-Tongshu Capsule (Enteric coated pellets) |
| Sanchi-Tongshu CapsuleTake 0.4g (2 Capsules) of reference preparation orally. | Drug | Sanchi-Tongshu Capsule |
Primary outcome
Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h)
Time frame: Up to 33 hours post dose
Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞)
Time frame: Up to 33 hours post dose
Maximum observed concentration (Cmax )
Time frame: Up to 33 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xihong Li, MD principal investigator
West China Second University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule in people with Healthy, run by Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h) (time frame: Up to 33 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.