PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01897428

Collaborator

Hanlim Pharm. Co., Ltd. (Industry)

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Urticaria Pruritus	Drug: Test-Bepotastine salicylate 9.64 mg Drug: Reference-bepotastine besilate 10 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Reference arm Treated with Reference (bepotastine besilate 10 mg)	Drug: Reference-bepotastine besilate 10 mg Other Names: Tarion Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea
Experimental: Test arm Treated with Test (bepotastine salicylate 9.64 mg)	Drug: Test-Bepotastine salicylate 9.64 mg Other Names: Berion Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea

Arm

Intervention/Treatment

Active Comparator: Reference arm

Treated with Reference (bepotastine besilate 10 mg)

Drug: Reference-bepotastine besilate 10 mg

Other Names:

Tarion

Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea

Experimental: Test arm

Treated with Test (bepotastine salicylate 9.64 mg)

Drug: Test-Bepotastine salicylate 9.64 mg

Other Names:

Berion

Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea

Outcome Measures

Primary Outcome Measures

bepotastine pharmacokinetics: peak plasma concentrations (Cmax) [24 hr]
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall) [24 hr]
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf) [24 hr]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

subjects aged between 20 and 45 years
Body weight > 50 kg (in case of female > 45 kg) with BMI between 18 and 29 kg/m2
Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion Criteria:

subjects with acute conditions.
presence of history affecting ADME
Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
Any other acute or chronic disease
A history of hypersensitivity to bepotastine
A history of alcohol or drug abuse
Participation in another clinical trial within 2 months
smoked >10 cigarettes daily
consumption over 5 glasses daily of beverages containing xanthine derivatives
use of any medication having the potential to affect the study results within 10 days before the start of the study.
medication of the inhibitors or inducers of DME including barbiturates within 1 month
one of abnormal lab findings as like
1. AST/ALT > UNL (upper normal limit) x 1.5
Total bilirubin > UNL x 1.5