Chinese Healthy VolunteersNCT02196805
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
A study testing Group A: imported Probucol ( Lorelco) and Group B: Marketed Probucol ( Chang Tai) in people with Chinese Healthy Volunteers, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent. 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
- Chinese Healthy Volunteers
- What is being tested?
- Group A: imported Probucol ( Lorelco) and Group B: Marketed Probucol ( Chang Tai)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Dec 2009
- Phase
- Interventional
- 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
- Chinese Male, aged between 18 and 40 years (at time of informed consent), extremes included
- Non-smokers
- Normal weight as defined by a Quetelet body mass index range of 18.0 - 26.0 kg/m2, extremes included
- Subjects judged by the investigator or sub investigator to be healthy based on the physical examination, medical history, vital signs, electrocardiogram (ECG), and the results of clinical laboratory tests
- Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study
- Willing to adhere to the study procedures described in this protocol
Who cannot join
- History of respiratory system disease, cardiovascular disease, Renal and Urogenital Disease, Gastrointestinal disease, hematological disease, Neuropsychiatric disease, endocrine diseases, hepatic disease or any other disease or physical condition which could have interfered with the interpretation of the study results
- Known hypersensitivity history to any prescription drug or over-the-counter medication
- Use of the following medications or products during the periods specified below:
- Any medication within 14 days prior to scheduled study drug administration; Alcohol and caffeine within 7 days prior to scheduled study drug administration; Grapefruit or grapefruit products within 14 days prior to scheduled study drug administration
- Participation in any other clinical trial within 12 weeks prior to scheduled study drug administration, or intention to participate any other clinical trial during the course of the study
- Significant loss or donation of blood or plasma (200 mL) within 30 days prior to the start of the study
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- Body weight <50kg
- History of drug abuse within past 5 years or positive urine drug screen results
- Subjects who test positive in HIV,HCV antibody,HBS antigen
- Otherwise judged by the investigator to be inappropriate for inclusion in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Pharmacology Research Center Peking Union Medical College Hospital
Beijing
About this study
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.
- Conditions
- Chinese Healthy Volunteers
- Being tested
- Group A: imported Probucol ( Lorelco), Group B: Marketed Probucol ( Chang Tai)
- Keywords
- bioequivalence, imported PROBUCOL table, Lorelco, marketed PROBUCOL tablet, Chang Tai
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: imported Probucol ( Lorelco)Drug
Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.
Group B: Marketed Probucol ( Chang Tai)Drug
Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Group A: imported Probucol ( Lorelco) |
| 2 | Experimental | Not described Receives: Drug: Group B: Marketed Probucol ( Chang Tai) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BE parameters: AUC0-t
Measured: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
BE parameters: Cmax
Measured: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
Secondary outcomes (5)
Pharmacokinetic Parameters: Cmax
Measured: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
Pharmacokinetic Parameters: Tmax
Measured: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-t
Measured: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-∞
Measured: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: t1/2
Measured: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chinese Healthy VolunteersStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pei Hu, Dr., Principal investigator, Clinical Pharmacology Research Center Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196805
- Sponsor's protocol ID
- 009-09-801-01
- Status last verified
- Jul 2014
- First submitted
- 25 Aug 2009
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02196805
- Acronym / sponsor ID
- 009-09-801-01
- Conditions
- Chinese Healthy Volunteers
- Keywords
- bioequivalence, imported PROBUCOL table, Lorelco, marketed PROBUCOL tablet, Chang Tai
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Jul 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.
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Group A: imported Probucol ( Lorelco) |
| 2 | Experimental | Drug: Group B: Marketed Probucol ( Chang Tai) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chinese Male, aged between 18 and 40 years (at time of informed consent), extremes included
- Non-smokers
- Normal weight as defined by a Quetelet body mass index range of 18.0 - 26.0 kg/m2, extremes included
- Subjects judged by the investigator or sub investigator to be healthy based on the physical examination, medical history, vital signs, electrocardiogram (ECG), and the results of clinical laboratory tests
- Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study
Key exclusion criteria (10 listed)
- History of respiratory system disease, cardiovascular disease, Renal and Urogenital Disease, Gastrointestinal disease, hematological disease, Neuropsychiatric disease, endocrine diseases, hepatic disease or any other disease or physical condition which could have interfered with the interpretation of the study results
- Known hypersensitivity history to any prescription drug or over-the-counter medication
- Use of the following medications or products during the periods specified below:
- Any medication within 14 days prior to scheduled study drug administration; Alcohol and caffeine within 7 days prior to scheduled study drug administration; Grapefruit or grapefruit products within 14 days prior to scheduled study drug administration
- Participation in any other clinical trial within 12 weeks prior to scheduled study drug administration, or intention to participate any other clinical trial during the course of 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 |
|---|---|---|
| Group A: imported Probucol ( Lorelco)Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O. | Drug | 1 |
| Group B: Marketed Probucol ( Chang Tai)Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O. | Drug | 2 |
Primary outcome
BE parameters: AUC0-t
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
BE parameters: Cmax
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
5 secondary outcomes
Pharmacokinetic Parameters: Cmax
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
Pharmacokinetic Parameters: Tmax
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-t
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-∞
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: t1/2
Time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
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 22 Jul 2014.
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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.
Pei Hu, Dr. principal investigator
Clinical Pharmacology Research Center Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: imported Probucol ( Lorelco) and Group B: Marketed Probucol ( Chang Tai) in people with Chinese Healthy Volunteers, run by Otsuka Beijing Research Institute 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 6 inclusion and 10 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 22 Jul 2014. 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.
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?
BE parameters: AUC0-t (time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.). The study lists 2 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 22 Jul 2014.