NCT01270984

Brief Summary

The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when administered a single-dose to healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1

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

November 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

1 month

First QC Date

January 4, 2011

Last Update Submit

October 30, 2012

Conditions

Chronic Myeloid LeukemiaGastrointestinal Stromal Tumors

Keywords

Imatinib mesylatePharmacokineticsHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects

    0-72hr

Secondary Outcomes (1)

  • To evaluate the safety of Luckyvec 400mg tablet and Glivec 100mg tablet from vital signs, physical exam, ECG, laboratory test, adverse event and so on.

    0-72hr

Study Arms (2)

Luckyvec 400mg film coated tablet

EXPERIMENTAL

400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)

Drug: Luckyvec 400mg film coated tablet

Glivec 100mg film coated tablet

ACTIVE COMPARATOR

100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)

Drug: Glivec 100mg film coated tablet

Interventions

Luckyvec 400mg film coated tabletDRUG

•400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)

Also known as: Luckyvec
Luckyvec 400mg film coated tablet
Glivec 100mg film coated tabletDRUG

•100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)

Also known as: Glivec
Glivec 100mg film coated tablet

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 20 aged and 45 aged in healthy males
  • BMI: 18\~29.9 kg/m2, (BMI = (체중 \[kg\])/(height \[m\])2)
  • Agreement with written informed consent

You may not qualify if:

  • Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, gastrointestinal system, immune system, skin system, nervous system or mental disease(Past history or present)
  • Subject with symptoms of acute disease within 28 days of starting administration of investigational drug
  • Subject with known for history which affect on the ADME of drug
  • Clinically significant active chronic disease
  • Inadequate result of laboratory test
  • AST/ALT \> 1.5 x UNL
  • Total bilirubin \> 1.5 x UNL
  • Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
  • Taking ETC(ethical the counter)medicine within 14 days
  • Taking OTC(Over the counter)medicine including oriental medicine within 7 days
  • Clinically significant allergic disease(Except for mild allergic rhinitis and dermatits seems to be not need for medication)
  • Subject with known for hypersensitivity reaction to imatinib analog
  • Not able to taking the institutional standard meal
  • Previously make whole blood donation within 60 days or component blood donation within 20 days
  • Previously have blood transfusion within 30 days
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Korea University Anam Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim KA, Park SJ, Kim C, Park JY. Single-dose, randomized crossover comparisons of different-strength imatinib mesylate formulations in healthy Korean male subjects. Clin Ther. 2013 Oct;35(10):1595-602. doi: 10.1016/j.clinthera.2013.08.008. Epub 2013 Sep 21.

    PMID: 24060561DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveGastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 6, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

KR(1)