HealthyPhase 1NCT06098261
Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects
A Phase 1 study testing Test (T) Bilastine and Reference (R) Bilastine in people with Healthy, run by The Affiliated Hospital of Qingdao University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test (T) Bilastine and Reference (R) Bilastine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2023to 27 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. 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; 2. Healthy male or female subjects ≥18 years of age; 3. Weight ≥50.0kg for men and ≥45.0kg for women; 4. Body mass index (BMI) within the range of 19.0~26.0kg/m2 (including threshold values); 5. 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; 6. 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; 7. Able to communicate well with the researcher and understand and comply with the requirements of this study.
- -
Who cannot join
- 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;
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- 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;
- Those who consumed an average of more than 14 units of alcohol per week (1 unit = 360milliliter of beer or 45milliliter of liquor at 40% alcohol by volume or 150milliliter of wine) in the past year, or who were unable to abstain from alcohol within 48 hours prior to study drug administration and or who are unable to abstain from alcohol during the trial, or who have an alcohol breath test result greater than 0.0 mg/100milliliter;
- Those who smoked ≥5 cigarettes per day in the 3 months prior to screening or who were unable to stop using any tobacco-based products, including any nicotine-containing cessation products, within 48 hours prior to study dosing and for the duration of the trial;
- History of substance abuse (including repeated, heavy non-medical use of all types of narcotic drugs and psychotropic substances) or drug use within 3 months prior to screening, or positive urine drug screens [including morphine, methamphetamine, ketamine, marijuana (tetrahydrocannabinolic acid), etc.] within 3 months prior to screening.(THC), etc.] are positive;
- Use of any non-steroidal anti-inflammatory drug or any drug that interacts with bilastine (ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, lorazepam, etc.) within 28 days prior to screening;
- Poor vascular puncture conditions, inability to tolerate venipuncture or a history of needle and blood phobia;
- Those who have difficulty in swallowing or have special dietary requirements and cannot accept a uniform diet and corresponding regulations;
- Those who ingested or were unable to stop ingesting any caffeine-containing, alcoholic beverages (including chocolate, tea, coffee, cola, etc.), as well as grapefruit or grapefruit products, and foods that interfere with the metabolism of the drug, such as dragon fruit, mango, pomelo, oranges, etc., in the 48h prior to the administration of the drug or during the trial period;
- Strenuous exercise within 1 week prior to screening, or inability to stop strenuous exercise during the test period;
- Those who, in the opinion of the investigator, have factors that make participation in this trial inadvisable;
- Use of oral contraceptives in the 30 days prior to the trial;
- Use of long-acting estrogen or progestin injections or implants in the 6 months prior to the trial;
- Women of childbearing age who have had unprotected sex with a partner in the 14 days prior to the test;
- Pregnant or lactating women. -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bioequivalence Trial of Bilastine Tablets in Healthy Subjects in a Single-Center, Open, Randomized, Single-Dose, Double-Cycle, Double-Crossover Fasting State
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
- Being tested
- Test (T) Bilastine, Reference (R) Bilastine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test (T) BilastineDrug
Specification: Bilastine 20mg. Produced and supplied by Shandong Hubble Kisen Biological Technology Co., Ltd.
Reference (R) BilastineDrug
Specification: Bilastine 20mg. Produced by Menarini International Operations Luxembourg S.A.
| Study group | Role | What they receive |
|---|---|---|
| Test (T)-Reference (R) | Experimental | 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. Receives: Drug: Test (T) Bilastine; Drug: Reference (R) Bilastine |
| Reference (R)-Test (T) | Experimental | 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. Receives: Drug: Test (T) Bilastine; Drug: Reference (R) Bilastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC0-t)
Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC0-∞)
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start21 Nov 2023 (estimated)
- Primary completion3 Dec 2023 (estimated)
- Study completion27 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098261
- Sponsor's protocol ID
- H-BLSTP-T-B-2023-HBKS-01
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Trial of Bilastine Tablets in Healthy Subjects in a Single-Center, Open, Randomized, Single-Dose, Double-Cycle, Double-Crossover Fasting State
- ClinicalTrials.gov ID
- NCT06098261
- Acronym / sponsor ID
- H-BLSTP-T-B-2023-HBKS-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (estimated)
- Primary completion
- 3 Dec 2023 (estimated)
- Study completion
- 27 Sep 2024 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (T)-Reference (R) | Experimental | Drug: Test (T) Bilastine, Drug: Reference (R) BilastineIn 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. |
| Reference (R)-Test (T) | Experimental | Drug: Test (T) Bilastine, Drug: Reference (R) BilastineIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. 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; 2. Healthy male or female subjects ≥18 years of age; 3. Weight ≥50.0kg for men and ≥45.0kg for women; 4. Body mass index (BMI) within the range of 19.0~26.0kg/m2 (including threshold values); 5. 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; 6. 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; 7. Able to communicate well with the researcher and understand and comply with the requirements of this study.
- -
Key exclusion criteria (23 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test (T) BilastineSpecification: Bilastine 20mg. Produced and supplied by Shandong Hubble Kisen Biological Technology Co., Ltd. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
| Reference (R) BilastineSpecification: Bilastine 20mg. Produced by Menarini International Operations Luxembourg S.A. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 48 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 48 hours
Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 48 hours
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test (T) Bilastine and Reference (R) Bilastine in people with Healthy, run by The Affiliated Hospital of Qingdao University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.