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

NCT01925313 | Completed Phase 1

• 1 other identifier: CJ_BEP_101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AUClast and Peak plasma concentration (Cmax) of Bepotastine

  Blood sampling up to 36hs post dose.

Secondary Outcomes (1)

• AUCinf, Tmax, T1/2 of Bepotastine

  Blood sampleing up to 36hrs post dose

Study Arms (2)

CJ-30044

EXPERIMENTAL

Drug: CJ-30044

TALION TAB. 10mg

ACTIVE COMPARATOR

Drug: TALION TAB. 10mg

Interventions

CJ-30044 DRUG

20.51mg a day,PO,QD

CJ-30044

TALION TAB. 10mg DRUG

10mg a day,PO,BID

TALION TAB. 10mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Yonsei university severance hospital

Seoul, South Korea

Location

Study Officials

• Min-Su Park, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 19, 2013

Record last verified: 2012-12

Locations

KR (1)