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

• Status: Completed
• Trial end date: 2019-05-28
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Bepotastine besilate

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.