NCT03932435

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fisrt period TWLO_C	First Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate 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)
DRUG	Second period TWLO	Second Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)

Timeline

• Start date: 2019-04-23
• Primary completion: 2019-05-28
• Completion: 2019-05-28
• First posted: 2019-04-30
• Last updated: 2020-02-10

Locations

1 site across 1 country: South Korea