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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

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