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

Chong Kun Dang

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: CKD-4101 tablet

Drug: Mycophenolate Mofetil capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01016626

123HPS08E

CKD-123HPS08E

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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