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

NCT ID: NCT01925313

Last Updated: 2013-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-05-31

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.

Conditions

Healthy

Keywords

Safety; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CJ-30044

Group Type: EXPERIMENTAL

CJ-30044

Intervention Type: DRUG

20.51mg a day,PO,QD

TALION TAB. 10mg

Group Type: ACTIVE_COMPARATOR

TALION TAB. 10mg

Intervention Type: DRUG

10mg a day,PO,BID

Interventions

CJ-30044

20.51mg a day,PO,QD

Intervention Type: DRUG

TALION TAB. 10mg

10mg a day,PO,BID

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-Su Park, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Yonsei university severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_BEP_101

Identifier Type: -

Identifier Source: org_study_id