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

NCT03932435 | Completed

• 1 other identifier: TWLO_BE_01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Before administration ~ 12 hours

• Peak Plasma Concentration(Cmax) of Bepotastine Besilate

  Before administration ~ 12 hours

Study Arms (2)

TWLO_C → TWLO

EXPERIMENTAL

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

TWLO → TWLO_C

EXPERIMENTAL

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

Fisrt period TWLO_C DRUG

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"

TWLO_C → TWLO

Fisrt period TWLO DRUG

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

Also known as: "Twolion Tab"

TWLO → TWLO_C

Washout period OTHER

7 days

TWLO → TWLO_C; TWLO_C → TWLO

Second period TWLO_C DRUG

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"

TWLO → TWLO_C

Second period TWLO DRUG

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

Also known as: "Twolion Tab"

TWLO_C → TWLO

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A person who aged 19 or older at the time of screening
• No congenital or chronic diseases or pathological symptoms on screening
• A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
• BMI of 18 to 30 (BMI calculation: kg/m2)
• No history of gastrointestinal resection that may affect the absorption of drugs
• No medical history of mental illness within five years prior to screening
• 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
• A person who is willing and able to follow all scheduled hospitalization and outpatient visits, medications, clinical laboratory examination and the terms of compliance
• Female patients who were confirmed to be not pregnant at medical examination

You may not qualify if:

• 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
• A person who uses drugs that can affect the study within 10 days before screening
• A person who is considered unsuitable to participate in the study by the investigator
• A person who has participated in other clinical trials within three months prior to the first administration of the IP
• A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before screening
• A person who is hypersensitive to venipuncture
• 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)
• Hypersensitive to any of the IP components
• 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
• Lactating women
• 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.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-dose, 2-sequence

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 30, 2019
• Study Start: April 23, 2019
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

KR (1)