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 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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CJ-30044; Drug: TALION TAB. 10mg

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CJ-30044	Drug: CJ-30044; 20.51mg a day,PO,QD
ACTIVE_COMPARATOR: TALION TAB. 10mg	Drug: TALION TAB. 10mg; 10mg a day,PO,BID

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Min-Su Park, PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: August 15, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (ESTIMATE): August 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2013
• Last Update Submitted That Met QC Criteria: August 15, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics
• Other Study ID Numbers: CJ_BEP_101