Clinical trial · Interventional
Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
NCT01270984CI-TRIAL-00008374ImatinibcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glivec 100mg film coated tablet | Drug | — | UNRESOLVED |
| Luckyvec 400mg film coated tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Luckyvec 400mg film coated tablet
- description
- 400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)
- interventionNames
- Drug: Luckyvec 400mg film coated tablet
- type
- ACTIVE_COMPARATOR
- label
- Glivec 100mg film coated tablet
- description
- 100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)
- interventionNames
- Drug: Glivec 100mg film coated tablet
Primary outcomes (1)
- measure
- To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim KA, Park SJ, Kim C, Park JY. Single-dose, randomized crossover comparisons of different-strength imatinib mesylate formulations in healthy Korean male subjects. Clin Ther. 2013 Oct;35(10):1595-602. doi: 10.1016/j.clinthera.2013.08.008. Epub 2013 Sep 21. PMID 24060561