Diabetes MellitusPhase 1NCT01039896
A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects
A Phase 1 study testing Period I : SLM0807, Period II : HKB0701 and SLM0807 and Period I : HKB0710 and SLM0807, Period II : SLM0807 in people with Diabetes Mellitus, run by HK inno.N Corporation.
Trial summary
The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Period I : SLM0807, Period II : HKB0701 and SLM0807 and Period I : HKB0710 and SLM0807, Period II : SLM0807
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Aug 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
- Available for the entire study period
- Willing to adhere to protocol requirements and sign a informed consent form.
Who cannot join
- Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
- Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
- Subjects with a history of clinically significant allergies including drug allergies
- Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.25 times to normal range or total bilirubin > 1.5times to normal range)
- Subjects with a history of drug, caffeine or alcohol abuse (caffeine drink >5cups /day, alcohol >30g/day)
- Heavy smoker ( >10cigarettes/day)
Show all 11Show fewer
- Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
- Subjects who have donated plasma within 60days prior to drug administration
- Subjects who have participated in a clinical study within 90days prior to drug administration
- Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator (cimetidine within 7days prior to drug administration)
- Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
About this study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Safety and Pharmacokinetics After Multiple Administration of SLM0807 Alone and Multiple Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.
- Conditions
- Diabetes Mellitus
- Being tested
- Period I : SLM0807, Period II : HKB0701 and SLM0807, Period I : HKB0710 and SLM0807, Period II : SLM0807
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period I : SLM0807, Period II : HKB0701 and SLM0807Drug
Period I : HKB0710 and SLM0807, Period II : SLM0807Drug
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | SLM0807 Receives: Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807 |
| Group2 | Experimental | SLM0807 and HKB0701 Receives: Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Css,max and AUCinf
Measured: up to 24hrs
Secondary outcomes (1)
AUCtau, AUCt, Tmax
Measured: up to 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Gook Shin, MD, ph D, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039896
- Sponsor's protocol ID
- CJ_VCM_101
- Status last verified
- Feb 2013
- First submitted
- 23 Dec 2009
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HS, Oh M, Kim EJ, Song GS, Ghim JL, Shon JH, Kim DH, Shin JG. Effect of voglibose on the pharmacokinetics of metformin in healthy Korean subjects. Int J Clin Pharmacol Ther. 2014 Nov;52(11):1005-11. doi: 10.5414/CP202160.
PubMed 25161160
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Evaluate the Safety and Pharmacokinetics After Multiple Administration of SLM0807 Alone and Multiple Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
- ClinicalTrials.gov ID
- NCT01039896
- Acronym / sponsor ID
- CJ_VCM_101
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Dec 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.
The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807SLM0807 |
| Group2 | Experimental | Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807SLM0807 and HKB0701 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
- Available for the entire study period
- Willing to adhere to protocol requirements and sign a informed consent form.
Key exclusion criteria (11 listed)
- Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
- Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
- Subjects with a history of clinically significant allergies including drug allergies
- Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.25 times to normal range or total bilirubin > 1.5times to normal range)
- Subjects with a history of drug, caffeine or alcohol abuse (caffeine drink >5cups /day, alcohol >30g/day)
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 |
|---|---|---|
| Period I : SLM0807, Period II : HKB0701 and SLM0807 | Drug | Group1 |
| Period I : HKB0710 and SLM0807, Period II : SLM0807 | Drug | Group2 |
Primary outcome
Css,max and AUCinf
Time frame: up to 24hrs
1 secondary outcome
AUCtau, AUCt, Tmax
Time frame: up to 24hrs
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 Feb 2013.
- Derived from this study: PubMed 25161160Kim HS, Oh M, Kim EJ, Song GS, Ghim JL, Shon JH, Kim DH, Shin JG. Effect of voglibose on the pharmacokinetics of metformin in healthy Korean subjects. Int J Clin Pharmacol Ther. 2014 Nov;52(11):1005-11. doi: 10.5414/CP202160.
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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.
Jae Gook Shin, MD, ph D principal investigator
Inje University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Period I : SLM0807, Period II : HKB0701 and SLM0807 and Period I : HKB0710 and SLM0807, Period II : SLM0807 in people with Diabetes Mellitus, run by HK inno.N Corporation.
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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Css,max and AUCinf (time frame: up to 24hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039896, which also lists 1 linked publication.
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 Feb 2013.