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Bioequivalence Test of "Dong-a Bepotastine Besilate Tab" and "Twolion Tab"

NCT03932435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-02-10

No results posted yet for this study

Summary

An Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers

Conditions

  • Healthy

Interventions

DRUG

Fisrt period TWLO_C

First Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate Tab"(Bepotastine Besilate 10mg)

DRUG

Fisrt period TWLO

First Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)

OTHER

Washout period

7 days

DRUG

Second period TWLO_C

Second Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate Tab"(Bepotastine Besilate 10mg)

DRUG

Second period TWLO

Second Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2019-05-28
Completion
2019-05-28

Countries

  • South Korea

Study Locations

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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 NCT03932435 on ClinicalTrials.gov