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

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01016626
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: CKD-4101 tablet
Drug: Mycophenolate Mofetil capsule
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 Tablet, in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule. [ Time Frame: 0-48 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 0-48 hrs ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016626

Locations
Korea, Republic of
The Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Ji Young Park jypark21@korea.ac.kr
  More Information

No publications provided

Responsible Party: Ji Hye Lee, Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01016626     History of Changes
Other Study ID Numbers: CKD-123HPS08E, 123HPS08E
Study First Received: November 18, 2009
Last Updated: November 18, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Pharmacokinetics
Healthy volunteers
Mycophenolate Mofetil

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013