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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CKD-4101 tablet; Drug: Mycophenolate Mofetil capsule

• Registration Number: NCT01016626
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Status Verified: 2009-11
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-18
• Last Update Submitted: 2009-11-18
• Study First Posted: 2009-11-19
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CKD-4101 tablet	CKD-4101 tablet	-
Mycophenolate Mofetil capsule	Mycophenolate Mofetil capsule	-

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule.	0-48 hrs

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of