Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects (NCT01270984) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
South Korea30 participantsStarted 2010-11
Plain-language 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.
Who can participate
Age range20 Years – 45 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sm…
What they're measuring
1
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects