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

The Affiliated Hospital of Qingdao University0 sites40 target enrollmentNovember 21, 2023

ConditionsHealthy

InterventionsTest (T) Bilastine Reference (R) Bilastine

DrugsTest (T) Bilastine Reference (R) Bilastine

Overview

Phase: Phase 1
Intervention: Test (T) Bilastine
Conditions: Healthy
Sponsor: The Affiliated Hospital of Qingdao University
Enrollment: 40
Primary Endpoint: Peak Plasma Concentration (Cmax)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 21, 2023

End Date

September 27, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

The Affiliated Hospital of Qingdao University

Responsible Party

Principal Investigator

Cao Yu

Director of Clinical Trials Center of Affiliated Hospital of Qingdao University

The Affiliated Hospital of Qingdao University

Eligibility Criteria

Inclusion Criteria

•Subjects are fully aware of the purpose, nature, methodology and possible adverse effects of the experiment, volunteer to be subjects, and sign an informed consent form prior to the start of all study procedures;
•Healthy male or female subjects ≥18 years of age;
•Weight ≥50.0kg for men and ≥45.0kg for women;
•Body mass index (BMI) within the range of 19.0\~26.0kg/m2 (including threshold values);
•Vital signs examination, physical examination, clinical laboratory tests (blood tests, urine tests, blood biochemistry tests, coagulation tests, infectious disease screening, etc.), 12-lead electrocardiograms, which show normal results or are judged by the investigating physician to be abnormal but not clinically significant;
•All subjects of childbearing potential (including the male subject's partner) who do not plan to have children and voluntarily use appropriate and effective contraception from the time of signing up to 6 months after the end of the trial, and who do not plan to donate sperm or eggs;
•Able to communicate well with the researcher and understand and comply with the requirements of this study.

Exclusion Criteria

•Allergy, e.g., a known history of allergy to a substance, or a known history of allergy to Bilastine and its excipients, or a history of other allergic diseases (asthma, urticaria, eczematous dermatitis);
•Those who develop an acute illness during the pre-study screening phase or prior to study drug administration;
•Those with a history of the following diseases or chronic/severe medical conditions that the investigator believes are still clinically significant, including but not limited to cardiovascular, digestive, genitourinary, respiratory, hematologic, endocrine, immune, psychoneurologic, and skeletal systems;
•especially those with gastrointestinal dysfunction, peptic ulcer, gastrointestinal diseases, and other conditions that may affect the absorption, distribution, metabolism, and excretion of medications;
•Those with a history of QT prolongation and/or tip-twist ventricular tachycardia (including a history of congenital long QT syndrome);
•Who have had surgery within 6 months prior to screening, or plan to have surgery during the study, or who have had or plan to have surgery that would interfere with the absorption, distribution, metabolism, or excretion of the drug;
•Those who have been vaccinated within 4 weeks prior to the trial or who plan to receive any vaccine during the trial or within 1 week of the end of the study;
•Those who have used any medications (including prescription, over-the-counter, herbal, nutraceuticals, and functional vitamins) within 2 weeks prior to screening;
•Participation in another clinical trial with an investigational drug or medical device intervention within 3 months prior to screening;
•Have received a blood transfusion or used blood products within 3 months prior to screening, or have a history of blood donation, or have lost more than 400milliliter of blood for other reasons, or plan to donate blood or blood components during the study or within 1 week of study completion;

Arms & Interventions

Test (T)-Reference (R)

In this trial, 40 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 7 days. After fasting for at least 10 hours.

Intervention: Test (T) Bilastine

Test (T)-Reference (R)

Intervention: Reference (R) Bilastine

Reference (R)-Test (T)

In this trial, 40 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 7 days. After fasting for at least 10 hours.

Intervention: Test (T) Bilastine