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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01270984
First received: January 4, 2011
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Myeloid Leukemia
Gastrointestinal Stromal Tumors
 Drug: Luckyvec 400mg film coated tablet
Drug: Glivec 100mg film coated tablet
 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 Luckyvec 400mg Tablet, in Healthy Subjects

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 Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]

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. [ Time Frame: 0-72hr ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Glivec

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270984

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: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01270984     History of Changes
Other Study ID Numbers: 131HPS10D
Study First Received: January 4, 2011
Last Updated: October 30, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Imatinib mesylate
Pharmacokinetics
Healthy volunteers

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Gastrointestinal Stromal Tumors
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013