NCT06098261

Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test (T) Bilastine	Specification: Bilastine 20mg. Produced and supplied by Shandong Hubble Kisen Biological Technology Co., Ltd.
DRUG	Reference (R) Bilastine	Specification: Bilastine 20mg. Produced by Menarini International Operations Luxembourg S.A.

Timeline

• Start date: 2023-11-21
• Primary completion: 2023-12-03
• Completion: 2024-09-27
• First posted: 2023-10-24
• Last updated: 2023-10-24