- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02648854
Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers
February 5, 2016 updated by: Chong Kun Dang Pharmaceutical
A Randomized, Open-label, Single Dose, 2-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers
This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.
Study Overview
Status
Completed
Conditions
Detailed Description
To healthy male subjects of 16, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Group 1: CKD-395 0.5/1000mg 1T(Fasting) / CKD-395 0.5/1000mg 1T(Fed) Group 2: CKD-395 0.5/1000mg 1T(Fed) / CKD-395 0.5/1000mg 1T(Fasting) Pharmacokinetic blood samples are collected up to 48hrs.
Investigate the effect of food on the pharmacokinetic characteristics of CKD-395
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Jeonju-si, Jeollabuk-do
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Deokjin-gu, Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
- Chonbuk National University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
a. 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group 1
<Group 1> Period 1: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (Fasting condition) 7 days for wash out Period 2: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (High fat meal fed condition)
|
administered CKD-395 0.5/1000mg 1T to oral (fasting condition)
Other Names:
administered CKD-395 0.5/1000mg 1T to oral (High fat meal fed condition)
Other Names:
|
Other: Group 2
<Group 2> Period 1: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (High fat meal fed condition) 7 days for wash out Period 2: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (Fasting condition)
|
administered CKD-395 0.5/1000mg 1T to oral (fasting condition)
Other Names:
administered CKD-395 0.5/1000mg 1T to oral (High fat meal fed condition)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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, 10, 12, 24 and 48hrs
|
0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 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
|
0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
|
Cmax of Metformin
Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
|
0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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, 10, 12, 24 and 48hrs
|
0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 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
|
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
|
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
|
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
|
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: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
|
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: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
|
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: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
|
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: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
|
0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
December 21, 2015
First Submitted That Met QC Criteria
January 5, 2016
First Posted (Estimate)
January 7, 2016
Study Record Updates
Last Update Posted (Estimate)
February 8, 2016
Last Update Submitted That Met QC Criteria
February 5, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 158BE15007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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