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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

Conditions
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Urticaria, Allergic Rhinitis, Pruritus

Intervention / Treatment
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* Drug: Test-Bepotastine salicylate 9.64 mg
* Drug: Reference-bepotastine besilate 10 mg


Participation Criteria
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Eligibility Criteria
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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 c. AST/ALT > UNL (upper normal limit) x 1.5 Total bilirubin > UNL x 1.5

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference arm<br>Treated with Reference (bepotastine besilate 10 mg) | Drug: Reference-bepotastine besilate 10 mg<br> <br> * Other names: Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea;|
| Experimental: Test arm<br>Treated with Test (bepotastine salicylate 9.64 mg) | Drug: Test-Bepotastine salicylate 9.64 mg<br> <br> * Other names: Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |