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Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects

NCT06098261 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2023-12-03
Completion
2024-09-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06098261 on ClinicalTrials.gov