NCT01016626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

Enrollment Period

1 month

First QC Date

November 18, 2009

Last Update Submit

November 18, 2009

Conditions

Healthy

Keywords

PharmacokineticsHealthy volunteersMycophenolate Mofetil

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule.

    0-48 hrs

Secondary Outcomes (1)

  • 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

Study Arms (2)

CKD-4101 tablet

EXPERIMENTAL
Drug: CKD-4101 tablet

Mycophenolate Mofetil capsule

ACTIVE COMPARATOR
Drug: Mycophenolate Mofetil capsule

Interventions

CKD-4101 tabletDRUG

CKD-4101 tablet 1000 mg * 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)

CKD-4101 tablet
Mycophenolate Mofetil capsuleDRUG

Mycophenolate Mofetil capsule 1000 mg * 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)

Mycophenolate Mofetil capsule

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Ji Young Park

    jypark21@korea.ac.kr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

KR(1)