Clinical trial NCT01925313: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Pharmacokinetics
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-19
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUClast and Peak plasma concentration (Cmax) of Bepotastine
timeFrame: Blood sampling up to 36hs post dose.
Secondary outcomes:
measure: AUCinf, Tmax, T1/2 of Bepotastine
timeFrame: Blood sampleing up to 36hrs post dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university severance hospital
Study officials:
affiliation: Severance Hospital
name: Min-Su Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: