Recruitment

Recruitment Status
Completed

Inclusion Criterias

Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
Male volunteers in the age between 20 and 55 years old
Willing to adhere to protocol requirements and sign a informed consent form
...
Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
Male volunteers in the age between 20 and 55 years old
Willing to adhere to protocol requirements and sign a informed consent form
Available for the entire study period
Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion Criterias

Participated in a previous clinical trial within 3 months prior to dosing
grapefruit juice > 4 cups/day
Estimated GFR(Glomerular Filtration Rate) < 80 mL/min
...
Participated in a previous clinical trial within 3 months prior to dosing
grapefruit juice > 4 cups/day
Estimated GFR(Glomerular Filtration Rate) < 80 mL/min
History of clinically significant allergies, including imatinib
History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg
smoking > 20 cigarettes/day
Donated blood within 60 days prior to dosing
AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range
caffeine > 4 cups/day
DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg
Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing
alcohol > 140g/week
History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
Subjects considered as unsuitable based on medical judgement by investigators

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 20 years and 55 years
Gender
Only males

Inclusion Criterias

Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
Male volunteers in the age between 20 and 55 years old
Willing to adhere to protocol requirements and sign a informed consent form
...
Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
Male volunteers in the age between 20 and 55 years old
Willing to adhere to protocol requirements and sign a informed consent form
Available for the entire study period
Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion Criterias

Participated in a previous clinical trial within 3 months prior to dosing
grapefruit juice > 4 cups/day
Estimated GFR(Glomerular Filtration Rate) < 80 mL/min
...
Participated in a previous clinical trial within 3 months prior to dosing
grapefruit juice > 4 cups/day
Estimated GFR(Glomerular Filtration Rate) < 80 mL/min
History of clinically significant allergies, including imatinib
History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg
smoking > 20 cigarettes/day
Donated blood within 60 days prior to dosing
AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range
caffeine > 4 cups/day
DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg
Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing
alcohol > 140g/week
History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
Subjects considered as unsuitable based on medical judgement by investigators

Locations

Seoul, 135-710
Seoul, 135-710

Tracking Information

NCT #
NCT01926548
Collaborators
Not Provided
Investigators
Not Provided