Clinical trial NCT01016626: Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 Tablet, in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Healthy volunteers
Mycophenolate Mofetil
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 28
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule.
timeFrame: 0-48 hrs
Secondary outcomes:
measure: 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.
timeFrame: 0-48 hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Korea University Anam Hospital
Study officials:
affiliation: jypark21@korea.ac.kr
name: Ji Young Park
role: PRINCIPAL_INVESTIGATOR
References: