Healthy
Conditions
Keywords
Safety, Pharmacokinetics
Brief summary
Study objectives * To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers. * To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers.
Interventions
DRUGCJ-30044
20.51mg a day,PO,QD
DRUGTALION TAB. 10mg
10mg a day,PO,BID
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male volunteers in the age between 20 and 45 years old * BMI(Body Mass Index) in the range of 18.5 to 25kg/m2 2. Subject with no history of any significant chronic disease 3. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators 4. Willing to adhere to protocol requirements and sign a informed consent form
Exclusion criteria
1. History of clinically significant allergies, including Bepotastine. 2. History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease 3. History of surgery except or gastrointestinal disease which might significantly change absorption of medicines 4. Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators. 5. Clinical laboratory test values are outside the accepted normal range * AST or ALT \>1.25 times to normal range * Total bilirubin \>1.5 times to normal range 6. Estimated GFR(Glomerular Filtration Rate) \< 80 mL/min/1.73m2 7. Clinically significant vital sign * SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg * DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg 8. History of drug abuse or positive urine screen for drugs 9. History of caffeine, alcohol, smoking abuse * caffeine \> 5 cups/day * alcohol \> 210g/week * smoking \> 10 cigarettes/day 10. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration 11. Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing 12. Participated in a previous clinical trial within 60 days prior to dosing 13. Donated blood within 60 days prior to dosing 14. Subjects considered as unsuitable based on medical judgement by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast and Peak plasma concentration (Cmax) of Bepotastine | Blood sampling up to 36hs post dose. |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, Tmax, T1/2 of Bepotastine | Blood sampleing up to 36hrs post dose |
Countries
South Korea
Outcome results
None listed