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

• Sponsor: HK inno.N Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01925313
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: CJ-30044; Drug: TALION TAB. 10mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUClast and Peak plasma concentration (Cmax) of Bepotastine [Blood sampling up to 36hs post dose.]

Secondary Outcome Measures

1. AUCinf, Tmax, T1/2 of Bepotastine [Blood sampleing up to 36hrs post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

1. Subject with no history of any significant chronic disease

2. 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

3. 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

1. Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2

2. Clinically significant vital sign

• SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg

• DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg

1. History of drug abuse or positive urine screen for drugs

2. History of caffeine, alcohol, smoking abuse

• caffeine > 5 cups/day

• alcohol > 210g/week

• smoking > 10 cigarettes/day

1. 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

2. 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

3. Participated in a previous clinical trial within 60 days prior to dosing

4. Donated blood within 60 days prior to dosing

5. Subjects considered as unsuitable based on medical judgement by investigators

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei university severance hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• HK inno.N Corporation

Investigators

• Principal Investigator: Min-Su Park, PhD, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HK inno.N Corporation
• ClinicalTrials.gov Identifier: NCT01925313
• Other Study ID Numbers: CJ_BEP_101
• First Posted: Aug 19, 2013
• Last Update Posted: Aug 19, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by HK inno.N Corporation: Safety; Pharmacokinetics

Study Results

No Results Posted as of Aug 19, 2013