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

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT01270984

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

30.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia Gastrointestinal Stromal Tumors	Drug: Luckyvec 400mg film coated tablet Drug: Glivec 100mg film coated tablet	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects [0-72hr]

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. [0-72hr]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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