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

Phase 1

Completed

• Conditions: Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumors
• Interventions: Drug: Glivec 100mg film coated tablet; Drug: Luckyvec 400mg film coated tablet

• Registration Number: NCT01270984
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-30
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glivec 100mg film coated tablet	Glivec 100mg film coated tablet	100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)
Luckyvec 400mg film coated tablet	Luckyvec 400mg film coated tablet	400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects	0-72hr

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of