Healthy Male VolunteerPhase 1CKD-501 DDINCT01133431
The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea
A Phase 1 study testing CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet in people with Healthy Male Volunteer, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy 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 Male Volunteer
- What is being tested?
- CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Aug 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
- Healthy male adults aged between 20 and 45 during screening period
- Weight more than 45kg and within ±20% range of Ideal Boby Weight
- Agreement with written informed consent
Who cannot join
- Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
- Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
- Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
- Inadequate laboratory test result
- AST(SGOT) or ALT(SGPT) > 1.25 x upper limit of normal range
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- Total bilirubin > 1.5 x upper limit of normal range
- Clinically significant allergic disease(except for mild allergic rhinitis is not needed medication)
- Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
- Previously participated in other trial within 60 days
- Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
- Subject has taken abnormal meals which affects the ADME of drug
- Impossible to taking the institutional standard meal
- Previously donate whole blood within 60 days or component blood within 20 days
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.
- Conditions
- Healthy Male Volunteer
- Being tested
- CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet, CKD-501 placebo tablet, Glimepiride 4 mg tablet
- Keywords
- CKD-501, Glimepiride, Placebo, Healthy male volunteer, Pharmacokinetic, Metabolite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-501 0.5 mg tablet, Glimepiride 4 mg tabletDrug
Also called CKD-501 : Lobeglitazone
From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.
CKD-501 placebo tablet, Glimepiride 4 mg tabletDrug
Also called CKD-501 : Lobeglitazone
From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.
| Study group | Role | What they receive |
|---|---|---|
| CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride | Experimental | This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. Receives: Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet; Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet |
| CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride | Experimental | This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. Receives: Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet; Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects
Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period
Measured: 0-24 hrs
Secondary outcomes (1)
To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501
Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period
Measured: 0-24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteerStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ji Young Park, Ph.D., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133431
- Sponsor's protocol ID
- CKD-19HPS10A
- Acronym
- CKD-501 DDI
- Status last verified
- May 2010
- First submitted
- 27 May 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study
- ClinicalTrials.gov ID
- NCT01133431
- Acronym / sponsor ID
- CKD-501 DDI / CKD-19HPS10A
- Conditions
- Healthy Male Volunteer
- Keywords
- CKD-501, Glimepiride, Placebo, Healthy male volunteer, Pharmacokinetic, Metabolite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 May 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.
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride | Experimental | Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet, Drug: CKD-501 placebo tablet, Glimepiride 4 mg tabletThis study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. |
| CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride | Experimental | Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet, Drug: CKD-501 placebo tablet, Glimepiride 4 mg tabletThis study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male adults aged between 20 and 45 during screening period
- Weight more than 45kg and within ±20% range of Ideal Boby Weight
- Agreement with written informed consent
Key exclusion criteria (16 listed)
- Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
- Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
- Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
- Inadequate laboratory test result
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 |
|---|---|---|
| CKD-501 0.5 mg tablet, Glimepiride 4 mg tabletAlso: CKD-501 : LobeglitazoneFrom day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1. | Drug | CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride, CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride |
| CKD-501 placebo tablet, Glimepiride 4 mg tabletAlso: CKD-501 : LobeglitazoneFrom day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2. | Drug | CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride, CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride |
Primary outcome
To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects
Time frame: 0-24 hrs
Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period
1 secondary outcome
To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501
Time frame: 0-24 hrs
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 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.
Ji Young Park, Ph.D. principal investigator
Korea University Anam Hospital
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 CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet in people with Healthy Male Volunteer, run by Chong Kun Dang 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 3 inclusion and 16 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 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.
What does the primary outcome measure?
To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects (time frame: 0-24 hrs). 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 Dec 2010.