HealthyPhase 4NCT01000467
Pharmacokinetics Study for Probucol
A Phase 4 study testing probucol in people with Healthy, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- probucol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Sep 2009
- Phase
- Phase 4
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Korean
- Male
- Age from 20 to 40 years at time of informed consent
- BMI more than 19.0 and less than 25.0
- Subjects who meet the following criteria at the time of the screening
- Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values
Who cannot join
- History or clinical evidence of significant medical history
- Present or previous significant drug allergy to any prescription or OTC medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.
Read the detailed description
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.
- Conditions
- Healthy
- Being tested
- probucol
- Keywords
- PK assessment for healthy male volunteer, Healthy male subjects aged 20 to 40 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probucolDrug
Also called Brand name: Lorelco
group 3: 250 mg 1 tablet in the morning and evening
probucolDrug
Also called lorelco
group 1: 250 mg
probucolDrug
Also called Lorelco
group 2: 250 mg 2 tablets at once in the morning
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Group 2(probucol 500mg BID) Receives: Drug: probucol |
| 1 | Active comparator | Group 1(Probucol 250mg) Receives: Drug: probucol |
| 3 | Active comparator | Group 3(Probucol 500mg once daily) Receives: Drug: probucol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionSep 2009
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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yoo, MD, PhD, Principal investigator, Clinical Trial Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000467
- Sponsor's protocol ID
- 009-KOB-0801i
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01000467
- Acronym / sponsor ID
- 009-KOB-0801i
- Conditions
- Healthy
- Keywords
- PK assessment for healthy male volunteer, Healthy male subjects aged 20 to 40 years
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Oct 2009 (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.
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.
Detailed description
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: probucolGroup 2(probucol 500mg BID) |
| 1 | Active comparator | Drug: probucolGroup 1(Probucol 250mg) |
| 3 | Active comparator | Drug: probucolGroup 3(Probucol 500mg once daily) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Korean
- Male
- Age from 20 to 40 years at time of informed consent
- BMI more than 19.0 and less than 25.0
- Subjects who meet the following criteria at the time of the screening
Key exclusion criteria (2 listed)
- History or clinical evidence of significant medical history
- Present or previous significant drug allergy to any prescription or OTC medication
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 |
|---|---|---|
| probucolAlso: Brand name: Lorelcogroup 3: 250 mg 1 tablet in the morning and evening | Drug | 3 |
| probucolAlso: lorelcogroup 1: 250 mg | Drug | 1 |
| probucolAlso: Lorelcogroup 2: 250 mg 2 tablets at once in the morning | Drug | 2 |
Primary outcome
Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.
Time frame: 1 month
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 4 Mar 2022.
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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.
Kyung-Sang Yoo, MD, PhD principal investigator
Clinical Trial Center, Seoul National 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 4 study testing probucol in people with Healthy, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 2 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 4 Mar 2022. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc. (time frame: 1 month). 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 4 Mar 2022.