The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

Study Overview
=================
Brief Summary
-----------------
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.

Official Title
-----------------
Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study

Conditions
-----------------
Healthy Male Volunteer

Intervention / Treatment
-----------------
* Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
* Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride<br>This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. | Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet<br>* 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.<br>* Other names: CKD-501 : Lobeglitazone;Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet<br>* 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.<br>* Other names: CKD-501 : Lobeglitazone;|
| Experimental: CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride<br>This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea. | Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet<br>* 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.<br>* Other names: CKD-501 : Lobeglitazone;Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet<br>* 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.<br>* Other names: CKD-501 : Lobeglitazone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0-24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0-24 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD-501, Glimepiride, Placebo, Healthy male volunteer, Pharmacokinetic, Metabolite