Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-17 @ 2:42 PM
Study NCT ID:
NCT06098261
Status:
UNKNOWN
Last Update Posted:
2023-10-24
First Post:
2023-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
Study Overview
Official Title:
Bioequivalence Trial of Bilastine Tablets in Healthy Subjects in a Single-Center, Open, Randomized, Single-Dose, Double-Cycle, Double-Crossover Fasting State
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: