Drug Interaction Between CKD-501 and Metformin

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.

Detailed Description
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Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days. In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days. Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.

Official Title
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A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: Metformin
* Drug: CKD-501


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 20 aged and 45 aged in healthy males Weight more than 55kg, IBW 20% within the range FPG 70 125 mg/dL Agreement with written informed consent Exclusion Criteria: Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned Test drug may affect the absorption of the gastrointestinal disease or a history that has learned Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg Substance abuse, or a history of drug abuse showed a positive for the party Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking Previously participated in other trial within 2 months Medication within 2 months make whole blood donation or medication within 1 month in component blood donation Continued to be drunk or during clinical trials can not be drunk 10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke Containing grapefruit foods ingested during clinical trials or can not be ingested Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD501<br> | Drug: Metformin<br>* CKD-501 0.5mg, metformin 1000mg<br>* Other names: Lobeglitazone;Drug: CKD-501<br>* CKD-501 0.5mg, metformin 1000mg<br>* Other names: Lobeglitazone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CKD - 501 and metformin Pharmacokinetics evaluation |  | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CKD-501 and metformin safety evaluation |  | 16 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mellitus, type 2, pharmacokinetic evaluation, drug interaction between CKD-501 and metformin