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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CKD-4101 tablet; Drug: Mycophenolate Mofetil capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-4101 tablet	Drug: CKD-4101 tablet; CKD-4101 tablet 1000 mg; 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)
Active Comparator: Mycophenolate Mofetil capsule	Drug: Mycophenolate Mofetil capsule; Mycophenolate Mofetil capsule 1000 mg; 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Ji Young Park, jypark21@korea.ac.kr

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 18, 2009
• First Posted (Estimate): November 19, 2009

Study Record Updates

• Last Update Posted (Estimate): November 19, 2009
• Last Update Submitted That Met QC Criteria: November 18, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Healthy volunteers; Pharmacokinetics; Mycophenolate Mofetil
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: CKD-123HPS08E; 123HPS08E