Healthy Male VolunteersPhase 1CKD-19HPS09HNCT01005160
Drug Interaction Between CKD-501 and Metformin
A Phase 1 study testing Metformin and CKD-501 in people with Healthy Male Volunteers, run by Chong Kun Dang Pharmaceutical.
Trial summary
The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers. 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 Male Volunteers
- What is being tested?
- Metformin and CKD-501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Feb 2010
- 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
- Between 20 aged and 45 aged in healthy males
- Weight more than 55kg, IBW 20% within the range
- FPG 70~125 mg/dL
- Agreement with written informed consent
Who cannot join
- Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned
- Test drug may affect the absorption of the gastrointestinal disease or a history that has learned
- Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party
- AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min
- systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg
- Substance abuse, or a history of drug abuse showed a positive for the party
Show all 13Show fewer
- Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
- Previously participated in other trial within 2 months
- Medication within 2 months make whole blood donation or medication within 1 month in component blood donation
- Continued to be drunk or during clinical trials can not be drunk
- 10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke
- Containing grapefruit foods ingested during clinical trials or can not be ingested
- Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested
About this study
Official title: A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers
The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.
Read the detailed description
Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days.
In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days.
Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.
- Conditions
- Healthy Male Volunteers
- Being tested
- Metformin, CKD-501
- Keywords
- Mellitus, type 2, pharmacokinetic evaluation, drug interaction between CKD-501 and metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Lobeglitazone
CKD-501 0.5mg, metformin 1000mg
CKD-501Drug
Also called Lobeglitazone
CKD-501 0.5mg, metformin 1000mg
| Study group | Role | What they receive |
|---|---|---|
| CKD501 | Experimental | Not described Receives: Drug: Metformin; Drug: CKD-501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CKD - 501 and metformin Pharmacokinetics evaluation
Measured: 16 days
Secondary outcomes (1)
CKD-501 and metformin safety evaluation
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionFeb 2010
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 Healthy Male 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kyung S Yu, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005160
- Sponsor's protocol ID
- CKD-19HPS09H
- Other IDs
- 19HPS09H
- Acronym
- CKD-19HPS09H
- Status last verified
- Oct 2009
- First submitted
- 28 Oct 2009
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Shin D, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Assessment of the pharmacokinetics of co-administered metformin and lobeglitazone, a thiazolidinedione antihyperglycemic agent, in healthy subjects. Curr Med Res Opin. 2012 Jul;28(7):1213-20. doi: 10.1185/03007995.2012.703131. Epub 2012 Jul 2.
PubMed 22697273
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01005160
- Acronym / sponsor ID
- CKD-19HPS09H / CKD-19HPS09H
- Conditions
- Healthy Male Volunteers
- Keywords
- Mellitus, type 2, pharmacokinetic evaluation, drug interaction between CKD-501 and metformin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 30 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.
The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.
Detailed description
Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days.
In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days.
Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD501 | Experimental | Drug: Metformin, Drug: CKD-501 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 20 aged and 45 aged in healthy males
- Weight more than 55kg, IBW 20% within the range
- FPG 70~125 mg/dL
- Agreement with written informed consent
Key exclusion criteria (13 listed)
- Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned
- Test drug may affect the absorption of the gastrointestinal disease or a history that has learned
- Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party
- AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min
- systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg
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 |
|---|---|---|
| MetforminAlso: LobeglitazoneCKD-501 0.5mg, metformin 1000mg | Drug | CKD501 |
| CKD-501Also: LobeglitazoneCKD-501 0.5mg, metformin 1000mg | Drug | CKD501 |
Primary outcome
CKD - 501 and metformin Pharmacokinetics evaluation
Time frame: 16 days
1 secondary outcome
CKD-501 and metformin safety evaluation
Time frame: 16 days
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 12 Jan 2011.
- Derived from this study: PubMed 22697273Shin D, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Assessment of the pharmacokinetics of co-administered metformin and lobeglitazone, a thiazolidinedione antihyperglycemic agent, in healthy subjects. Curr Med Res Opin. 2012 Jul;28(7):1213-20. doi: 10.1185/03007995.2012.703131. Epub 2012 Jul 2.
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Health Volunteers
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 S Yu principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin and CKD-501 in people with Healthy Male Volunteers, run by Chong Kun Dang Pharmaceutical.
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 4 inclusion and 13 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 12 Jan 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?
CKD - 501 and metformin Pharmacokinetics evaluation (time frame: 16 days). 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 NCT01005160, 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 12 Jan 2011.