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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03932435

Recruitment Status Completed

First Posted April 30, 2019

Last update posted February 10, 2020

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:Healthy
  • Intervention/Treatment: Drug: Fisrt period TWLO_C
    Drug: Fisrt period TWLO
    Other: Washout period
    Drug: Second period TWLO_C
    Drug: Second period TWLO
  • Phase: 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. 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

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 32 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: single-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: April 2019
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 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: Washout period
7 days

Drug: Second period TWLO
Second Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)
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: 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)
Outcome Measures
  • Primary Outcome Measures: 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 ]
Eligibility Criteria
  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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)

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.

Contacts and Locations
Contacts
Locations

Korea, Republic of
H Plus Yangji Hospital
Seoul

Sponsors and Collaborators

Dong-A ST Co., Ltd.

More Information
  • Responsible Party: Dong-A ST Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03932435 History of Changes
  • Other Study ID Numbers: TWLO_BE_01
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: February 10, 2020
  • Last Verified: February 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No