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Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects

Healthy Clinical Trial

Official title:
Bioequivalence Trial of Bilastine Tablets in Healthy Subjects in a Single-Center, Open, Randomized, Single-Dose, Double-Cycle, Double-Crossover Fasting State

Clinical Trial Summary

Using a single-center, open, randomized, single-dose, double-cycle, double-crossover trial design method (washout period of 7 days), 40 screened and qualified healthy subjects were randomly divided into 2 groups, the T-R group and the R-T group, with 20 subjects in each group. The enrolled subjects entered the Phase I clinical research center 1 day prior to the first cycle of dosing, and fasted for 10 h or more prior to dosing. On the morning of the day of administration, 1 tablet of Bilastine (20 mg) developed by Shandong Hubble Kisen Biological Technology Co., Ltd. or 1 tablet of Bilastine (20 mg) licensed by Menarini International Operations Luxembourg S.A. were administered orally on an empty stomach.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06098261
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact Yu Cao
Phone 18661809090
Email caoyu1767@126.com
Status Not yet recruiting
Phase Phase 1
Start date November 21, 2023
Completion date September 27, 2024
View Details
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