CClinicalTrials.gg
CompletedNCT03932435Updated Feb 10, 2020

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

An interventional study of Fisrt period TWLO_C and Fisrt period TWLO in Healthy, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.

Sponsored by Dong-A ST Co., Ltd. · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

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

Read the 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.

  3. Wash out period: 7 days
  4. 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)
  5. Analysis: Measurement of the concentration of an unchangeable substance of Bepotastine in plasma
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
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

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)
  8. Hypersensitive to any of the IP components
  9. 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
  10. Lactating women
  11. 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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 · Other: Washout period · Drug: Second period TWLO

  • Experimental
    TWLO → TWLO_C

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

    Drug: Fisrt period TWLO · Other: Washout period · Drug: Second period TWLO_C

Interventions

  • DrugFisrt period TWLO_C

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

    Also known as: "Dong-a Bepotastine Besilate Tab"

  • DrugFisrt period TWLO

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

    Also known as: "Twolion Tab"

  • OtherWashout period

    7 days

  • DrugSecond period TWLO_C

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

    Also known as: "Dong-a Bepotastine Besilate Tab"

  • DrugSecond period TWLO

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

    Also known as: "Twolion Tab"

06

What researchers measure

Primary outcomes

  1. Area Under the plasma Concetration versus time curve(AUClast) of Bepotastine Besilate

    Time frame: Before administration ~ 12 hours

  2. Peak Plasma Concentration(Cmax) of Bepotastine Besilate

    Time frame: Before administration ~ 12 hours

07

Study locations

1 site
  • H Plus Yangji Hospital
    Seoul, 08779, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03932435
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Apr 30, 2019
Start date
Apr 23, 2019
Primary completion
May 28, 2019
Completion
May 28, 2019
Last update
Feb 10, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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