CKD-396 Drug-drug Interaction Study(B) (CKD-396 DDI(B) P1)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone in healthy male volunteers.

Detailed Description
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To healthy male subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.

Official Title
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A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Effect of Lobeglitazoneon Pharmacokinetics of Sitagliptin in Healthy Male Volunteers

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Januvia Tab. 100mg
* Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg


Participation Criteria
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Eligibility Criteria
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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, nercous, or allergic(except subclinical seasonal allergies that is not treated at injecion) desease. Who had a gistory 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%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g). Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial. Whose blood pressure ≤ 100 or ≥150(systolic blood pressure) or < 60 or ≥ 100(diastolic blood pressure). Who had a medical history of alcohol and drug abuses. Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion) in 30 days before the first taking of clinical testing durg. WHo smokes more than 20 eigarettes per day. Who took prescribed drugs or over-the-conuter durgs 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 sho can interrupt interpretin test results by having serious or chronic medical and mental status or having issues in results of the screening examination. Who has a histroy of an extreme sensitivity of drugs that contain the ingredients of Sitagliptin or thiazolidinediones drugs or drugs that contain Rosiglitazone or dugs that have similar effect a Rosiglitazone(Pioglitazone). Who has a serious heart failure or a congestive heart failure that must be drug-treated. A patient with hepatopathy. A patient with wevere nephropathy. Who has diabetic ketoacidosis or a diaetic coma, or type 1 diabetes, or has history of acute metablic 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. 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1(Treatment A/Treatment B)<br>Period 1: Treatment A(Januvia Tab. 100mg)*1T/day for 5 days, QD, PO. Period 2: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas. | Drug: Januvia Tab. 100mg<br>* Januvia Tab. 100mg*1T/day for 5days, QD, PO<br>* Other names: Sitagliptin 100mg;Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg<br>* Januvia Tab.100mg + Duvie Tab. 0.5mg*1T/day for 5 dyas, QD, PO<br>* Other names: Lobeglitazone 0.5mg;|
| Experimental: Group 2(Treatment B/Treatment A)<br>Period 1: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO. Period 2: Treatment A(Januvia Tab. 100mg)*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas. | Drug: Januvia Tab. 100mg<br>* Januvia Tab. 100mg*1T/day for 5days, QD, PO<br>* Other names: Sitagliptin 100mg;Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg<br>* Januvia Tab.100mg + Duvie Tab. 0.5mg*1T/day for 5 dyas, QD, PO<br>* Other names: Lobeglitazone 0.5mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| Css,max of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Css,min of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| Css,av of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| Tss,max of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| t1/2 of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| CLss/F of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| Vdss/F of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| fluctuation[(Css,max-Css,min)/Css,av] of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | 
| swing[(Css,max-Css,min)/Css,min] of Sitagliptin |  | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |