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
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
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.
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.
Exclusion Criteria:
A person with a history of regular alcohol intake within six months prior to screening:
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_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
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"
First Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)
Also known as: "Twolion Tab"
7 days
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"
Second Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)
Also known as: "Twolion Tab"
Area Under the plasma Concetration versus time curve(AUClast) of Bepotastine Besilate
Time frame: Before administration ~ 12 hours
Peak Plasma Concentration(Cmax) of Bepotastine Besilate
Time frame: Before administration ~ 12 hours
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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Dong-A ST Co., Ltd.