Diabetes MellitusPhase 1NCT01370681
A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject
A Phase 1 study testing Period I : HKB0701 and SLM0807, Period II : CJ30001 and Period I : CJ30001, Period II : HKB0701 and SLM0807 in people with Diabetes Mellitus, run by HK inno.N Corporation.
Trial summary
The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Period I : HKB0701 and SLM0807, Period II : CJ30001 and Period I : CJ30001, Period II : HKB0701 and SLM0807
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Nov 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 50 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 abuse(caffeine drink >5cups/day)
- Subjects with a history of alcohol abuse(alcohol>30g/day) or who have ever drinked alcohol whinin 7days prior to drug administration
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- Heavy smoker ( >10cigarettes/day)
- 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 within 10days prior to drug administration (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 Pharmacokinetics After Administration of CJ30001 and Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.
- Conditions
- Diabetes Mellitus
- Being tested
- Period I : HKB0701 and SLM0807, Period II : CJ30001, Period I : CJ30001, Period II : HKB0701 and 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 : HKB0701 and SLM0807, Period II : CJ30001Drug
Period I : CJ30001, Period II : HKB0701 and SLM0807Drug
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Not described Receives: Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001 |
| Group2 | Experimental | Not described Receives: Drug: Period I : CJ30001, Period II : HKB0701 and SLM0807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean Cmax
Measured: up to 24hrs
Geometric mean AUCt
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 posted10 Jun 2011 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jae Gook Shin, MD, ph D, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370681
- Sponsor's protocol ID
- CJ_VCM_102
- Status last verified
- Jun 2011
- First submitted
- 1 Jun 2011
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics After Administration of CJ30001 and Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
- ClinicalTrials.gov ID
- NCT01370681
- Acronym / sponsor ID
- CJ_VCM_102
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 Jun 2011 (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 objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.
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 : HKB0701 and SLM0807, Period II : CJ30001 |
| Group2 | Experimental | Drug: Period I : CJ30001, Period II : HKB0701 and SLM0807 |
Who may qualify
- Ages
- 20 to 50 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 (12 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 abuse(caffeine drink >5cups/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 : HKB0701 and SLM0807, Period II : CJ30001 | Drug | Group1 |
| Period I : CJ30001, Period II : HKB0701 and SLM0807 | Drug | Group2 |
Primary outcome
Geometric mean Cmax
Time frame: up to 24hrs
Geometric mean AUCt
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 10 Jun 2011.
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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 : HKB0701 and SLM0807, Period II : CJ30001 and Period I : CJ30001, Period II : HKB0701 and 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 12 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 10 Jun 2011. 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?
Geometric mean Cmax (time frame: up to 24hrs). 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 10 Jun 2011.