Diabetes Mellitus, Type IIPhase 1NCT02627027
A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers
A Phase 1 study testing Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg and CKD-395 0.25/750mg in people with Diabetes Mellitus, Type II, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg and CKD-395 0.25/750mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Sep 2015
- 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 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy man older than 19 years at the time of screening.
- BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
- Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
- Suitable subject who is determined by laboratory tests such as hematology tests,blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
- Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
- Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
Who cannot join
- Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Subjects who show AST or AST > 2 times upper limit of normal range.
- Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- Subjects who show Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg at screening.
Show all 27Show fewer
- Subjects who have history of alcohol or drug abuse, within 1 year
- Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- Smoker ( ≥ 20cigarettes/day)
- Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
- Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
- Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- Patients with hypersensitivity to lobeglitazone or any other thiazolidinediones ( Rosiglitazone, Rioglitazone) and to Metformin or any other biguanides
- Patients with severe heart failure or congestive heart failure of needing drug therapy
- Patients with liver disease
- Patients with severe renal disease
- Patients with diabetes mellitus with ketoacidosis, diabetes coma and prior
- Patients before or after surgery, with severe infections, severe trauma
- Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients with renal disease or renal failure caused by cardiovascular collapse, acute myocardial infarction, sepsis (Serum creatinine ≥ 1.5mg/dL or abnormal creatine clearance)
- Patients who had a test to injecting radioactive iodine in vein
- Patients with severe infections or severe traumatic whole body injuries
- Patients with undernourishment condition or starvation state or hyposthenia or hypopituitarism, or hypoadrenalism
- Patients with respiratory failure, or stomach disease
- Subjects who is not able to intake high fat meals
- Subjects who is not able to comply with guidelines described in the protocol.
- Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do
About this study
Official title: A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers
This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.
Read the detailed description
To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days.
Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glucodaun OR Tab. 750mg 2T Treatment B(Test Drug): CKD-395 0.25/750mg Tab. 2T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg, CKD-395 0.25/750mg
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mgDrug
Also called Lobeglitazone Sulfate 0.5mg, Metformin HCl 1500mg
oral administration
CKD-395 0.25/750mgDrug
Also called Lobeglitazone Sulfate 0.25mg, Metformin HCl 750mg
oral administration
| Study group | Role | What they receive |
|---|---|---|
| RT group | Experimental | R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) T: Test drug(CKD-395 0.25/750 mg 2T) Receives: Drug: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg; Drug: CKD-395 0.25/750mg |
| TR group | Experimental | T: Test drug(CKD-395 0.25/750 mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) Receives: Drug: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg; Drug: CKD-395 0.25/750mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of Lobeglitazone
Measured: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUClast of metformin
Measured: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Cmax of Lobeglitazone
Measured: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Cmax of Lobeglitazone Metformin
Measured: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Secondary outcomes (10)
AUCinf of Lobeglitazone
Measured: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUCinf of Metformin
Measured: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Tmax of Lobeglitazone
Measured: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Tmax of Metformin
Measured: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Measured: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
t1/2 of Metformin
Measured: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
CL/F of Lobeglitazone
Measured: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
CL/F of Metformin
Measured: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Vd/F of Lobeglitazone
Measured: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Vd/F of Metformin
Measured: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627027
- Sponsor's protocol ID
- 158BE15004
- Status last verified
- Jan 2016
- First submitted
- 8 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02627027
- Acronym / sponsor ID
- 158BE15004
- Conditions
- Diabetes Mellitus, Type II
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Dec 2015 (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 a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.
Detailed description
To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days.
Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glucodaun OR Tab. 750mg 2T Treatment B(Test Drug): CKD-395 0.25/750mg Tab. 2T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT group | Experimental | Drug: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg, Drug: CKD-395 0.25/750mgR: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) T: Test drug(CKD-395 0.25/750 mg 2T) |
| TR group | Experimental | Drug: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg, Drug: CKD-395 0.25/750mgT: Test drug(CKD-395 0.25/750 mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy man older than 19 years at the time of screening.
- BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
- Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
- Suitable subject who is determined by laboratory tests such as hematology tests,blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
- Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
Key exclusion criteria (27 listed)
- Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Subjects who show AST or AST > 2 times upper limit of normal range.
- Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
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 |
|---|---|---|
| Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mgAlso: Lobeglitazone Sulfate 0.5mg, Metformin HCl 1500mgoral administration | Drug | RT group, TR group |
| CKD-395 0.25/750mgAlso: Lobeglitazone Sulfate 0.25mg, Metformin HCl 750mgoral administration | Drug | RT group, TR group |
Primary outcome
AUClast of Lobeglitazone
Time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUClast of metformin
Time frame: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Cmax of Lobeglitazone
Time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Cmax of Lobeglitazone Metformin
Time frame: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
10 secondary outcomes
AUCinf of Lobeglitazone
Time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUCinf of Metformin
Time frame: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Tmax of Lobeglitazone
Time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Tmax of Metformin
Time frame: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
t1/2 of Metformin
Time frame: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
CL/F of Lobeglitazone
Time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
CL/F of Metformin
Time frame: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Vd/F of Lobeglitazone
Time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Vd/F of Metformin
Time frame: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
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 6 Jan 2016.
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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 Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg and CKD-395 0.25/750mg in people with Diabetes Mellitus, Type II, 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 6 inclusion and 27 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 6 Jan 2016. 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?
AUClast of Lobeglitazone (time frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs). The study lists 4 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 6 Jan 2016.