Healthy Adult MalePhase 1NCT01258699
A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects
A Phase 1 study testing Thiocacid HR Tab 600mg, BK-C-0701 320mg and BK-C-0701 480mg in people with Healthy Adult Male, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- Thiocacid HR Tab 600mg, BK-C-0701 320mg and BK-C-0701 480mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to not given
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male is between 20 and 45
- Weight is between 50 and 90kg, and in 20% of ideal weight. Ideal weight(kg)=(height(cm)-100)*0.9
- Medical history, physical examination, ECG and laboratory test are suitable to the study if judged by an investigator.
- Patient is willing to use an effective method of contraception during the study and for up to 1 months after the use of study drug ceases. (Effective method=spermicide with condom)
- Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Patient received drug affected to the study within 14 days from the study initiation.
- Patient received drug-metbolizing enzyme inducer or inhibitor such as Barbiturates within 1 month from the study initiation.
- Subject is hypersensitive investigational drug(Thioctic acid).
- Patient with gastrointestinal history affected absorbing investigational drug or inhibiting normal gastrointestinal motility, gastrointestinal operation or gastrointestinal wound.
- Patient with renal, hepatic, bronchopulmonary, cardiovascular, gastrointestinal, metabolic, neurological, psychotic, oncologic, allergic disease, myocardial infarction, cardiac crisis, hepatitis or pancreatitis history.
- ECG is abnormal.
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- Patient abused drug.
- Patient joined other clinical study within 3 months from the study initiation.
- Patient doanted whole blood within 2 months or plasma blood within 1 month from the first medication.
- HBsAg, HCV Ab or HIV Ab are positive.
- Patient who was not suitable to the study if judged by an investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects.
- Conditions
- Healthy Adult Male
- Being tested
- Thiocacid HR Tab 600mg, BK-C-0701 320mg, BK-C-0701 480mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiocacid HR Tab 600mgDrug
600mg for 1 day
BK-C-0701 320mgDrug
320mg for 1 day
BK-C-0701 480mgDrug
480mg for 1 day
| Study group | Role | What they receive |
|---|---|---|
| 3 | Experimental | BK-C-0701 480mg Receives: Drug: BK-C-0701 480mg |
| 2 | Experimental | BK-C-0701 320mg Receives: Drug: BK-C-0701 320mg |
| 1 | Active comparator | Thioctacid HR tab 600mg Receives: Drug: Thiocacid HR Tab 600mg |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258699
- Sponsor's protocol ID
- BK-C-0701-101
- Status last verified
- Dec 2010
- First submitted
- 10 Dec 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01258699
- Acronym / sponsor ID
- BK-C-0701-101
- Conditions
- Healthy Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- First posted
- 13 Dec 2010 (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 is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Experimental | Drug: BK-C-0701 480mgBK-C-0701 480mg |
| 2 | Experimental | Drug: BK-C-0701 320mgBK-C-0701 320mg |
| 1 | Active comparator | Drug: Thiocacid HR Tab 600mgThioctacid HR tab 600mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male is between 20 and 45
- Weight is between 50 and 90kg, and in 20% of ideal weight. Ideal weight(kg)=(height(cm)-100)*0.9
- Medical history, physical examination, ECG and laboratory test are suitable to the study if judged by an investigator.
- Patient is willing to use an effective method of contraception during the study and for up to 1 months after the use of study drug ceases. (Effective method=spermicide with condom)
- Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Key exclusion criteria (11 listed)
- Patient received drug affected to the study within 14 days from the study initiation.
- Patient received drug-metbolizing enzyme inducer or inhibitor such as Barbiturates within 1 month from the study initiation.
- Subject is hypersensitive investigational drug(Thioctic acid).
- Patient with gastrointestinal history affected absorbing investigational drug or inhibiting normal gastrointestinal motility, gastrointestinal operation or gastrointestinal wound.
- Patient with renal, hepatic, bronchopulmonary, cardiovascular, gastrointestinal, metabolic, neurological, psychotic, oncologic, allergic disease, myocardial infarction, cardiac crisis, hepatitis or pancreatitis history.
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 |
|---|---|---|
| Thiocacid HR Tab 600mg600mg for 1 day | Drug | 1 |
| BK-C-0701 320mg320mg for 1 day | Drug | 2 |
| BK-C-0701 480mg480mg for 1 day | Drug | 3 |
Primary outcome
Not reported in the source record.
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 13 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thiocacid HR Tab 600mg, BK-C-0701 320mg and BK-C-0701 480mg in people with Healthy Adult Male, run by Bukwang Pharmaceutical 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 5 inclusion and 11 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 13 Dec 2010. 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 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.
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 13 Dec 2010.