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Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects (Imatinib)

Primary Purpose

Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Luckyvec 400mg film coated tablet
Glivec 100mg film coated tablet
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Imatinib mesylate, Pharmacokinetics, Healthy volunteers

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Previously participated in other trial within 30 days
  • Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) and 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

Sites / Locations

  • The Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Luckyvec 400mg film coated tablet

Glivec 100mg film coated tablet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 4, 2011
Last Updated
October 30, 2012
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01270984
Brief Title
Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
Acronym
Imatinib
Official Title
Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Healthy volunteers are administrated single-dose over the period I and II (Crossover) of Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T)as of Imatinib 400mg. Every time before and after each medication, PK parameters and safety of Luckyvec 400mg tablet and Glivec 100mg is performed using a blood sample and conducting some tests(Laboratory test, V/S, Physical Examination, etc) respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors
Keywords
Imatinib mesylate, Pharmacokinetics, Healthy volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Luckyvec 400mg film coated tablet
Arm Type
Experimental
Arm Description
400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
Arm Title
Glivec 100mg film coated tablet
Arm Type
Active Comparator
Arm Description
100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)
Intervention Type
Drug
Intervention Name(s)
Luckyvec 400mg film coated tablet
Other Intervention Name(s)
Luckyvec
Intervention Description
•400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
Intervention Type
Drug
Intervention Name(s)
Glivec 100mg film coated tablet
Other Intervention Name(s)
Glivec
Intervention Description
•100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)
Primary Outcome Measure Information:
Title
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
Time Frame
0-72hr
Secondary Outcome Measure Information:
Title
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.
Time Frame
0-72hr

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Previously participated in other trial within 30 days Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) and 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Young Park
Organizational Affiliation
jypark21@korea.ac.kr
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24060561
Citation
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.
Results Reference
derived

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Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects

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