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

July 11, 2013 updated by: Ji-Young Park, Korea University Anam Hospital

Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 136-705
        • Dept. of Clinical Pharmacology & Toxicology, Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reference arm
Treated with Reference (bepotastine besilate 10 mg)
Other Names:
  • Tarion
  • Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea
Experimental: Test arm
Treated with Test (bepotastine salicylate 9.64 mg)
Other Names:
  • Berion
  • Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bepotastine pharmacokinetics: peak plasma concentrations (Cmax)
Time Frame: 24 hr
24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)
Time Frame: 24 hr
24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
Time Frame: 24 hr
24 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

July 12, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

March 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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