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

NCT01897428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-07-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Test-Bepotastine salicylate 9.64 mg

DRUG

Reference-bepotastine besilate 10 mg

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    collaborator INDUSTRY

  • Korea University Anam Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01897428 on ClinicalTrials.gov