Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered alone to healthy volunteers.

Detailed Description
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Healthy volunteers are administrated single-dose over the period I and II (Crossover) of CKD-4101 1000mg and Mycophenolate mofetil capsule 1000mg. Every time before and after each medication, PK parameters and safety of CKD-4101 tablet and Mycophenolate mofetil capsule is performed using a blood sample and conducting some tests respectively.

Official Title
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Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 Tablet, in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CKD-4101 tablet
* Drug: Mycophenolate Mofetil capsule


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 45 kg, IBW ± 20% within the range Ideal body weight = (Height cm - 100) x 0.9 Agreement with written informed consent Exclusion Criteria: Subject has symptoms of acute disease within 28 days of starting administration of investigational drug Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) which affect the ADME of drug Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, Blood system, digestive system, central nervous system, mental disease or malignancy disease. Inadequate subject by medical examination(medical history, physical examination,ECG, laboratory test) within 28 days of starting administration of investigational drug Inadequate result of laboratory test AST or ALT > 1.25 x upper limit of normal range Total bilirubin > 1.25 x upper limit of normal range Abnormal level of WBC, Platelet, Hemoglobin WBC < 3.5 x 1000/µL PLT < 100 x 1000/µL Hemoglobin < 11g/dL Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication) HGPRT(Hypoxanthine-guanine phosphoribosyl-transferase)deficiency patient such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome Severe renal dysfunction: Creatinine clearance less than 50ml/min by cockroft-Gault calculation Subject with known for hypersensitivity reaction to mycophenolic acid and mycophenolate mofetil analog Previously participated in other trial within 60 days Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1month or with may affect the clinical trial within 10 days Unusual diet may affect the ADME of drug Not able to taking the institutional standard meal Previously make whole blood donation within 60 days or component blood donation within 20 days Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) and during clinical trials can not be drunk or severe heavy smoker (cigarette > 1/2 pack per day) An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: CKD-4101 tablet<br> | Drug: CKD-4101 tablet<br>* CKD-4101 tablet 1000 mg 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)<br>|
| Active Comparator: Mycophenolate Mofetil capsule<br> | Drug: Mycophenolate Mofetil capsule<br>* Mycophenolate Mofetil capsule 1000 mg 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule. |  | 0-48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of CKD-4101 tablet and Mycophenolate Mofetil capsule from vital signs, physical exam, ECG, laboratory test, adverse event and so on. |  | 0-48 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Healthy volunteers, Mycophenolate Mofetil