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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03932435
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
27.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Fisrt period TWLO_C
  • Drug: Fisrt period TWLO
  • Other: Washout period
  • Drug: Second period TWLO_C
  • Drug: Second period TWLO
 N/A

Detailed Description

  1. Study design: An open-Label, randomized, 2-sequence, 2-period, fasted condition, single-dose, per oral, cross-over study

  2. Administration method:

The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Bepotastine Besilate 10 mg) with 150 mL of water at around 8 a.m. on the day of the test at room temperature. The test subject should not chew the drug or break it, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the collection time.

  1. Wash out period: 7 days

  2. Blood collection time: Before the administration, 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12 hr after the administration (total 13 times)

  3. Analysis: Measurement of the concentration of an unchangeable substance of Bepotastine in plasma

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
single-dose, 2-sequencesingle-dose, 2-sequence
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A 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
Actual Study Start Date :
Apr 23, 2019
Actual Primary Completion Date :
May 28, 2019
Actual Study Completion Date :
May 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: TWLO_C → TWLO

TWLO_C: "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg), TWLO: "Twolion Tab" (Bepotastine Besilate 10mg)

Drug: Fisrt period TWLO_C
First Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate Tab"(Bepotastine Besilate 10mg)
Other Names:
  • "Dong-a Bepotastine Besilate Tab"

    • Other: Washout period
    7 days

    Drug: Second period TWLO
    Second Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)
    Other Names:
  • "Twolion Tab"

    		•
    Experimental: TWLO → TWLO_C

    TWLO_C: "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg), TWLO: "Twolion Tab" (Bepotastine Besilate 10mg)

    Drug: Fisrt period TWLO
    First Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)
    Other Names:
  • "Twolion Tab"

    • 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)
    Other Names:
  • "Dong-a Bepotastine Besilate Tab"

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the plasma Concetration versus time curve(AUClast) of Bepotastine Besilate [Before administration ~ 12 hours]

    2. Peak Plasma Concentration(Cmax) of Bepotastine Besilate [Before administration ~ 12 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. A person who aged 19 or older at the time of screening

    2. No congenital or chronic diseases or pathological symptoms on screening

    3. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination

    4. BMI of 18 to 30 (BMI calculation: kg/m2)

    5. No history of gastrointestinal resection that may affect the absorption of drugs

    6. No medical history of mental illness within five years prior to screening

    7. A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature

    8. A person who is willing and able to follow all scheduled hospitalization and outpatient visits, medications, clinical laboratory examination and the terms of compliance

    9. Female patients who were confirmed to be not pregnant at medical examination

    Exclusion Criteria:

    1. A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to screening

    2. A person who uses drugs that can affect the study within 10 days before screening

    3. A person who is considered unsuitable to participate in the study by the investigator

    4. A person who has participated in other clinical trials within three months prior to the first administration of the IP

    5. A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before screening

    6. A person who is hypersensitive to venipuncture

    7. A person with a history of regular alcohol intake within six months prior to screening:

    • Women: More than 14 cups/week

    • Men: More than 21 glasses/week (1 shot: 50 ml of soju, 30 ml of spirits, 250 ml of beer)

    1. Hypersensitive to any of the IP components

    2. Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 2 times or γ-GTP levels exceed the upper reference range limit by 1.5 times

    3. Lactating women

    4. A person who does not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the IP until the 7th day after the last administration.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H Plus Yangji Hospital Seoul Korea, Republic of 08779

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03932435
    Other Study ID Numbers:
    • TWLO_BE_01
    First Posted:
    Apr 30, 2019
    Last Update Posted:
    Feb 10, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bepotastine besilate

    Study Results

    No Results Posted as of Feb 10, 2020