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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-08-31

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.

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Detailed Description

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Conditions

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Allergic Rhinitis Urticaria Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Reference arm

Treated with Reference (bepotastine besilate 10 mg)

Group Type ACTIVE_COMPARATOR

Reference-bepotastine besilate 10 mg

Intervention Type DRUG

Test arm

Treated with Test (bepotastine salicylate 9.64 mg)

Group Type EXPERIMENTAL

Test-Bepotastine salicylate 9.64 mg

Intervention Type DRUG

Interventions

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Test-Bepotastine salicylate 9.64 mg

Intervention Type DRUG

Reference-bepotastine besilate 10 mg

Intervention Type DRUG

Other Intervention Names

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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes