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

October 30, 2012 updated by: Chong Kun Dang Pharmaceutical

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Luckyvec 400mg film coated tablet
400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
Drug: Luckyvec 400mg film coated tablet
•400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
Other Names:
  • Luckyvec
Active Comparator: Glivec 100mg film coated tablet
100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)
Drug: Glivec 100mg film coated tablet
•100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)
Other Names:
  • Glivec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
Time Frame: 0-72hr
0-72hr

Secondary Outcome Measures

Outcome Measure
Time Frame
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
0-72hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Ji-Young Park, jypark21@korea.ac.kr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 30, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131HPS10D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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