NCT01925313CompletedPhase 1
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- HK inno.N Corporation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- AUClast and Peak plasma concentration (Cmax) of Bepotastine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
CJ-30044
Experimental
Intervention: CJ-30044 (Drug)
TALION TAB. 10mg
Active Comparator
Intervention: TALION TAB. 10mg (Drug)
Outcomes
Primary Outcomes
AUClast and Peak plasma concentration (Cmax) of Bepotastine
Time Frame: Blood sampling up to 36hs post dose.
Secondary Outcomes
- AUCinf, Tmax, T1/2 of Bepotastine(Blood sampleing up to 36hrs post dose)
Investigators
Study Sites (1)
Loading locations...
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