Drug-drug Interaction Study(CKD-501, Amlodipine)

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

Detailed Description
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Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.

Official Title
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A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-501
* Drug: amlodiopine
* Drug: CKD-501 amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 20 aged and 45 years old in healthy males Body weight ≥ 55kg and 18.5 ≤ IBW < 25 Agreement with written informed consent Exclusion Criteria: Subject has a history affects the ADME of drug Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) AST,ALT > UNL * 1.25 or Total bilirubin > UNL * 1.5 Estimated GFR(MDRD) < 80 SBP >150 mmHg, SBP < 100 mmHg or DBP > 100 mmHg, DBP < 60 mmHg or Pulse > 100 per/min, Pulse < 50 per/min Substance abuse, or a history of drug abuse showed a positive for the party Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking Subject takes grapefruit within 1 month Previously participated in other trial within 60 days Previously donate whole blood within 60 days or component blood within 30 days An impossible one who participates in clinical trial by investigator's decision including laboratory test result

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-501 0.5mg<br>Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days. | Drug: CKD-501<br>* Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.<br>* Other names: Lobeglitazone;|
| Experimental: CKD-501 Amlodipine<br>Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days. | Drug: CKD-501 amlodipine<br>* Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.<br>|
| Experimental: Amlodipine 10mg<br>Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days. | Drug: amlodiopine<br>* Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CKD-501 AUC |  | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr | 
| Amlodipine AUC |  | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CKD-5011 Tmax |  | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr | 
| Amlodipine Tmax |  | Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Drug interaction between the CKD-501 and Amlodipine