A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CJ-30044
* Drug: TALION TAB. 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male volunteers in the age between 20 and 45 years old BMI(Body Mass Index) in the range of 18.5 to 25kg/m2 Subject with no history of any significant chronic disease 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 Willing to adhere to protocol requirements and sign a informed consent form Exclusion Criteria: History of clinically significant allergies, including Bepotastine. History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease History of surgery except or gastrointestinal disease which might significantly change absorption of medicines Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators. 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 Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2 Clinically significant vital sign SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg History of drug abuse or positive urine screen for drugs History of caffeine, alcohol, smoking abuse caffeine > 5 cups/day alcohol > 210g/week smoking > 10 cigarettes/day 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 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 Participated in a previous clinical trial within 60 days prior to dosing Donated blood within 60 days prior to dosing Subjects considered as unsuitable based on medical judgement by investigators

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ-30044<br> | Drug: CJ-30044<br>* 20.51mg a day,PO,QD<br>|
| Active Comparator: TALION TAB. 10mg<br> | Drug: TALION TAB. 10mg<br>* 10mg a day,PO,BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast and Peak plasma concentration (Cmax) of Bepotastine |  | Blood sampling up to 36hs post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, Tmax, T1/2 of Bepotastine |  | Blood sampleing up to 36hrs post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Pharmacokinetics