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

Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01897428

Enrollment

Registered

2013-07-12

Start date

2011-04-30

Completion date

2011-08-31

Last updated

2013-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Pruritus, Urticaria

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.

Interventions

DRUGTest-Bepotastine salicylate 9.64 mg

DRUGReference-bepotastine besilate 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

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 * c. AST/ALT \> UNL (upper normal limit) x 1.5 * Total bilirubin \> UNL x 1.5

Design outcomes

Primary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026