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

NCT ID: NCT01016626

Last Updated: 2009-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-10-31

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Healthy volunteers; Mycophenolate Mofetil

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD-4101 tablet

Group Type: EXPERIMENTAL

CKD-4101 tablet

Intervention Type: DRUG

CKD-4101 tablet 1000 mg

• 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)

Mycophenolate Mofetil capsule

Group Type: ACTIVE_COMPARATOR

Mycophenolate Mofetil capsule

Intervention Type: DRUG

Mycophenolate Mofetil capsule 1000 mg

• 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)

Interventions

CKD-4101 tablet

CKD-4101 tablet 1000 mg

• 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)

Intervention Type: DRUG

Mycophenolate Mofetil capsule

Mycophenolate Mofetil capsule 1000 mg

• 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chong Kun Dang Pharmaceutical

Principal Investigators

Ji Young Park

Role: PRINCIPAL_INVESTIGATOR

jypark21@korea.ac.kr

Locations

The Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

123HPS08E

Identifier Type: -

Identifier Source: secondary_id

CKD-123HPS08E

Identifier Type: -

Identifier Source: org_study_id