Diabetes Mellitus, Type IIPhase 1NCT02685774

A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers

A Phase 1 study testing Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg and CKD-395 0.25/500mg in people with Diabetes Mellitus, Type II, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/500 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, Glucophage XR Tab. 500mg and CKD-395 0.25/500mg
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: Feb 2016to Apr 2016
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

A healthy male whose age is over 19 years old when visiting for initial screening test
Body mass index (BMI) between 17.5 ~ 30.5 kg/m^2 and the body weight must be over 55kg
Body mass index (BMI) = weight (kg) / height (m)^2
A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
The participants must have an ability and willingness to participate throughout the entire trials

Who cannot join

A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic (except subclinical seasonal allergies that is not treated at injection) disease.
Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
Who had following results after examination
ALT or AST > twice higher than normal value
Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12 g)
Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial

Show all 29Show fewer

Whose blood pressure > 140 mmHg (systolic blood pressure) or > 90 mmHg (diastolic pressure)
Who had a medical history of alcohol and drug abuses.
Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug
Who smokes more than 20 cigarettes per day
Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug
Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs.
Who has a potent to increase a danger by participating in the clinical trials or who can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
Who has a history of an extreme sensitivity of drugs that contain Rosiglitazone or drugs that have similar effect as Rosiglitazone (Pioglitazone), or drugs that contain the ingredients of Metformin or biguanidine drugs
Who has a serious heart failure or a congestive heart failure that must be drug-treated
A patient with hepatopathy
A patient with severe nephropathy
Who has diabetic ketoacidosis or a diabetic coma, or type 1 diabetes, or has history of acute metabolic acidosis or ketoacidosis
A patient with serious infectious disease or severe injuries before and after a surgery
Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
A patient who has kidney disease or renal insufficient that are caused by cardiovascular collapse (shock) and acute myocardial infarction (a male with higher serum creatinine of 1.5mg / dL, or less creatinine clearance of 80 mL / min)
A patient who is being tested to inject radiological iodine contrast agent into blood vessels (ex: intravenous urography, intravenous cholangiography, angiography, using contrast medium computer tomography, etc.)
Who has severe systematic infection or severe trauma
Who has nutritional status, starvation, debilitating condition, pituitary dysfunction, or adrenal insufficiency patients
Who has respiratory dysfunction, gastrointestinal disease
Who is unable to take high fat foods
Who cannot limit intake of grapefruit or grapefruit containing foods in 7 days from the first dosing of clinical testing drug to collect pharmacokinetic blood samples
Test subjects who is not willing or unable to comply with guidelines described in this protocol
A person who is not determined unsuitable to participate in this test by the researchers

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chonbuk National University Hospital
Jeonju, Jeollabuk-do

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500 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 0.25/500 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 + Glucophage XR Tab. 500mg 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, Glucophage XR Tab. 500mg, CKD-395 0.25/500mg
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, Glucophage XR Tab. 500mgDrug
Also called Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg
Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T oral administration
CKD-395 0.25/500mgDrug
CKD-395 0.25/500mg 2T oral administration

Study groups in NCT02685774
Study group	Role	What they receive
RT group	Other	R: Reference drug(Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T) T: Test drug(CKD-395 0.25/500mg 2T) Receives: Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg; Drug: CKD-395 0.25/500mg
TR group	Other	T: Test drug(CKD-395 0.25/500mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T) Receives: Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg; Drug: CKD-395 0.25/500mg

What is being measured

The primary outcome is the main question the study is designed to answer.

AUClast of Lobeglitazone
Measured: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Cmax of Lobeglitazone
Measured: 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: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Cmax of Metformin
Measured: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs

Secondary outcomes (10)

AUCinf of Lobeglitazone
Measured: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Tmax of Lobeglitazone
Measured: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Measured: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
CL/F of Lobeglitazone
Measured: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Vd/F of Lobeglitazone
Measured: 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: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Tmax of Metformin
Measured: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Measured: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
CL/F of Metformin
Measured: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Vd/F of Metformin
Measured: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 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.

Feb 2016Apr 2016

First posted19 Feb 2016 (estimated)
Study startFeb 2016
Primary completionMar 2016
Study completionApr 2016

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02685774
Sponsor's protocol ID: 158BE15032
Status last verified: Aug 2017
First submitted: 15 Feb 2016
Last updated: 9 Aug 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2017. 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 0.25/500 mg in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02685774
Acronym / sponsor ID: 158BE15032
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: Feb 2016 (actual)
Primary completion: Mar 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 19 Feb 2016 (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 0.25/500 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 + Glucophage XR Tab. 500mg 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	Other	Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg, Drug: CKD-395 0.25/500mgR: Reference drug(Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T) T: Test drug(CKD-395 0.25/500mg 2T)
TR group	Other	Drug: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg, Drug: CKD-395 0.25/500mgT: Test drug(CKD-395 0.25/500mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T)

Who may qualify

Ages: 19 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

A healthy male whose age is over 19 years old when visiting for initial screening test
Body mass index (BMI) between 17.5 ~ 30.5 kg/m^2 and the body weight must be over 55kg
A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.

Key exclusion criteria (29 listed)

A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic (except subclinical seasonal allergies that is not treated at injection) disease.
Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
Who had following results after examination
Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12 g)
Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial

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, Glucophage XR Tab. 500mgAlso: Duvie Tab. 0.5mg, Glucophage XR Tab. 500mgDuvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T oral administration	Drug	RT group, TR group
CKD-395 0.25/500mgCKD-395 0.25/500mg 2T oral administration	Drug	RT group, TR group

Primary outcome

AUClast of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Cmax of Lobeglitazone
Time frame: 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: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Cmax of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs

10 secondary outcomes

AUCinf of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Tmax of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
CL/F of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Vd/F of Lobeglitazone
Time frame: 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: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Tmax of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
CL/F of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Vd/F of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 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 9 Aug 2017.
Individual participant dataSharing planned: No

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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, Glucophage XR Tab. 500mg and CKD-395 0.25/500mg 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 7 inclusion and 29 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 9 Aug 2017. 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: 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?

On the ClinicalTrials.gov record for NCT02685774.

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 9 Aug 2017.