Healthy
Conditions
Keywords
Pharmacokinetics, Healthy volunteers, Mycophenolate Mofetil
Brief summary
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
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.
Interventions
DRUGCKD-4101 tablet
CKD-4101 tablet 1000 mg * 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)
DRUGMycophenolate Mofetil capsule
Mycophenolate Mofetil capsule 1000 mg * 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule. | 0-48 hrs |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed