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

Chronic Myeloid Leukemia Clinical Trial

— Imatinib  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270984
• Other study ID #: 131HPS10D
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2011
• Last updated: October 30, 2012
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2012
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Between 20 aged and 45 aged in healthy males

• BMI: 18~29.9 kg/m2, (BMI = (?? [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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Gastrointestinal Stromal Tumors
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Luckyvec 400mg film coated tablet
•400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
• Glivec 100mg film coated tablet
•100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)

Locations

Country	Name	City	State
Korea, Republic of	The Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects		0-72hr	No
Secondary	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	No