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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ-30044; Drug: TALION TAB. 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01925313

CJ_BEP_101

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

CJ-30044

Experimental group

Treatment:

Drug: CJ-30044

TALION TAB. 10mg

Active Comparator group

Treatment:

Drug: TALION TAB. 10mg