Epilepsy (treatment Refractory)Phase 1BENCT06762743

Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions

A Phase 1 study testing Brivaracetam Oral Solution (Test Formulation) and Brivaracetam Oral Solution (Reference Formulation) in people with Epilepsy (treatment Refractory), run by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The goal of this clinical trial is to evaluate the bioequivalence of Brivaracetam oral solution under fasting and high-fat meal conditions in healthy adults. The study will compare a test formulation (produced by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., 300ml: 3g) to the reference formulation (Briviact®, UCB… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy (treatment Refractory)
What is being tested?: Brivaracetam Oral Solution (Test Formulation) and Brivaracetam Oral Solution (Reference Formulation)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 21 Oct 2024to 31 Dec 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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age and Gender: Healthy male and female participants aged 18-55 years (inclusive).
Weight and BMI: Male participants must weigh ≥50 kg, and females ≥45 kg, with a body mass index (BMI) between 19 and 26. BMI is calculated as: BMI = weight (kg) / height (m²).
Participants must fully understand the purpose, methods, content, and test drugs of this study before enrollment, be capable of good communication with investigators, adhere to study requirements, and voluntarily sign the informed consent form.
Participants must commit to avoiding pregnancy and refraining from sperm/egg donation from the time of consent through 3 months after the last dose. Participants must agree to use effective contraception (non-pharmacological methods) during the trial. Female participants must have had no unprotected sexual activity within 14 days before the first dose.

Who cannot join

History of allergies (e.g., angioedema, anaphylactic shock) or hypersensitivity (e.g., to pollen, two or more drugs/foods), or known allergy to briciclib or its excipients.
Past or current illnesses that may affect drug absorption, distribution, metabolism, excretion, or the interpretation of safety data, or conditions reducing compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, oncological, immunological, psychiatric, or cardiovascular diseases, as judged by the investigator.
Major surgery within 3 months prior to screening or planned surgery during the study period, including procedures affecting pharmacokinetics (e.g., gallbladder/biliary tract surgery).
History of significant bleeding, active bleeding, thrombocytopenia, coagulation disorders, or family history of coagulopathy.
Vaccination within 28 days prior to screening or planned vaccination during the study.
History of substance abuse or dependence within the past 5 years or use of drugs such as morphine, methamphetamine, ketamine, cannabis, or ecstasy within 6 months before screening. Positive urine drug screen results are also exclusionary.

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Difficulty with venipuncture, intolerance to venous puncture, or history of needle or blood phobia.
Lactose intolerance.
Special dietary requirements that cannot align with standardized study diets.
Participation in any clinical trial and drug administration within 3 months prior to screening.
Blood donation or significant blood loss (≥400 mL) within 3 months prior to screening (excluding physiological blood loss in women) or intention to donate blood during the study.
Regular smokers (≥5 cigarettes/day) or habitual betel nut chewers within 3 months prior to screening, or inability to abstain from tobacco products during the study.
Frequent alcohol consumption (more than 14 units per week, where 1 unit = 360 mL beer, 45 mL spirits, or 150 mL wine) within 3 months prior to screening, positive breath alcohol test, or inability to abstain from alcohol during the study.
Excessive intake of tea, coffee, caffeine-containing products, grapefruit, or xanthine-rich foods or beverages (e.g., theophylline, caffeine, theobromine) averaging more than 8 cups/day (1 cup = 200 mL) within 3 months prior to screening or inability to discontinue such intake during the study.
Use of any medications, including prescription, over-the-counter drugs, herbal medicines, or health supplements, within 14 days prior to the first dose.
Use of any liver enzyme-altering drugs within 28 days prior to the first dose.
Pregnant or lactating women, or females with positive pregnancy tests.
Positive results for any of the following virological tests: Hepatitis B surface antigen, Hepatitis C antibody, HIV antibody, or syphilis antibody.
Clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or laboratory tests at screening, as determined by the investigator.
Other reasons that may prevent the participant from completing the study, or any other factors deemed unsuitable for participation by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, Jiangsu, 210033

Other trials in China

About this study

Official title: A Randomized, Open-Label, Two-Formulation, Two-Period, Crossover Bioequivalence Study of Oral Brivaracetam Solution Administered As a Single Dose Under Fasting and High-fat Meal Conditions in Healthy Subjects

The main questions it aims to answer are:

Do the test and reference formulations of Brivaracetam oral solution exhibit similar pharmacokinetic behavior in the body?
What are the clinical safety outcomes for participants taking the test and reference formulations?

Participants will:

Be randomly assigned to two treatment sequences (T-R or R-T) in a 1:1 ratio. Receive either the test formulation or reference formulation of Brivaracetam oral solution (10ml), taken with 240mL of warm water, under either fasting or high-fat meal conditions.

Cross over to the alternate formulation after a 7-day washout period, completing a total of two treatment periods (2 weeks).

Undergo regular checkups and tests to monitor pharmacokinetics and safety outcomes.

Conditions: Epilepsy (treatment Refractory)
Being tested: Brivaracetam Oral Solution (Test Formulation), Brivaracetam Oral Solution (Reference Formulation)
Keywords: crossover, bioequivalence, Brivaracetam Oral Solution
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brivaracetam Oral Solution (Test Formulation)Drug
The drug is manufactured by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.
Brivaracetam Oral Solution (Reference Formulation)Drug
Also called Briviact®
The drug is manufactured by UCB Pharma S.A. under the trade name Briviact®. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.

Study groups in NCT06762743
Study group	Role	What they receive
Fasting group	Experimental	Participants in fasting group will first receive a single oral dose of the test formulation of Brivaracetam oral solution in the first period, followed by a washout period, and then a single oral dose of the reference formulation of Brivaracetam oral solution in the second period. Receives: Drug: Brivaracetam Oral Solution (Test Formulation); Drug: Brivaracetam Oral Solution (Reference Formulation)
High-fat meal group	Experimental	Participants will first receive a single oral dose of the reference formulation of Brivaracetam oral solution in the first period, followed by a washout period, and then a single oral dose of the test formulation of Brivaracetam in the second period. Receives: Drug: Brivaracetam Oral Solution (Test Formulation); Drug: Brivaracetam Oral Solution (Reference Formulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration of the drug following a single oral dose. This parameter reflects the peak exposure to the drug in the bloodstream after administration.
Measured: two weeks
Area Under the Plasma Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-t)
AUC0-t represents the total drug exposure from time 0 to the last measurable concentration. It is an important pharmacokinetic parameter for understanding the extent of drug absorption over time.
Measured: two weeks
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞)
AUC0-∞ is the area under the plasma concentration-time curve from time 0 to infinity, capturing the total exposure to the drug. It includes all measurable concentrations, both during and after the absorption phase.
Measured: two weeks

Secondary outcomes (4)

Time to Reach Maximum Plasma Concentration(Tmax )
Tmax is the time it takes to reach the maximum plasma concentration (Cmax) after a single dose of the drug. It indicates the rate at which the drug is absorbed into the bloodstream.
Measured: two weeks
Terminal Elimination Rate Constant (λz)
λz is the terminal elimination rate constant, which is used to describe the rate at which the drug is cleared from the body during the elimination phase. This value helps estimate the half-life of the drug.
Measured: two weeks
Half-life (t1/2)
t1/2 is the time required for the plasma concentration of the drug to decrease by half. It is a key pharmacokinetic parameter to understand the duration of action of the drug.
Measured: two weeks
Percentage of the Area Under the Curve Extrapolated to Infinity(AUC_%Extrap )
AUC_%Extrap is the percentage of the total AUC that is extrapolated beyond the last measured concentration (AUC∞ - AUC0-t) / AUC∞. This indicates the reliability of the AUC data and how much data is based on extrapolated values.
Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202431 Dec 2024

First posted8 Jan 2025
Study start21 Oct 2024
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Epilepsy (treatment Refractory)Studies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: A two-period, two-sequence crossover design where participants are randomly assigned to receive either the test or reference formulation in a fasted or fed state, with a washout period of seven days between treatments.
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06762743
Sponsor's protocol ID: 240605-BLXT-HBE
Acronym: BE
Status last verified: Jul 2024
First submitted: 23 Dec 2024
Last updated: 8 Jan 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Velazquez J, Acosta J, Herrera N, Morales A, Gonzalez O, Herrera F, Estrada MP, Carpio Y. Novel IFNgamma homologue identified in Nile tilapia (Oreochromis niloticus) links with immune response in gills under different stimuli. Fish Shellfish Immunol. 2017 Dec;71:275-285. doi: 10.1016/j.fsi.2017.10.014. Epub 2017 Oct 7.
PubMed 29017941
Aranake A, Mashour GA, Avidan MS. Minimum alveolar concentration: ongoing relevance and clinical utility. Anaesthesia. 2013 May;68(5):512-22. doi: 10.1111/anae.12168. Epub 2013 Feb 16.
PubMed 23414556
Cho SY, Kwon YK, Nam M, Vaidya B, Kim SR, Lee S, Kwon J, Kim D, Hwang GS. Integrated profiling of global metabolomic and transcriptomic responses to viral hemorrhagic septicemia virus infection in olive flounder. Fish Shellfish Immunol. 2017 Dec;71:220-229. doi: 10.1016/j.fsi.2017.10.007. Epub 2017 Oct 7.
PubMed 29017947
Tsilidis KK, Panagiotou OA, Sena ES, Aretouli E, Evangelou E, Howells DW, Al-Shahi Salman R, Macleod MR, Ioannidis JP. Evaluation of excess significance bias in animal studies of neurological diseases. PLoS Biol. 2013 Jul;11(7):e1001609. doi: 10.1371/journal.pbio.1001609. Epub 2013 Jul 16.
PubMed 23874156
Zhu M, Tao Y, Pu J, Zhao H, Wan L, Zhang P, Tang C. Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4-Way Replicate Crossover Study. Clin Pharmacol Drug Dev. 2023 Jan;12(1):30-37. doi: 10.1002/cpdd.1137. Epub 2022 Jul 6.
PubMed 35794358

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Two-Formulation, Two-Period, Crossover Bioequivalence Study of Oral Brivaracetam Solution Administered As a Single Dose Under Fasting and High-fat Meal Conditions in Healthy Subjects
ClinicalTrials.gov ID: NCT06762743
Acronym / sponsor ID: BE / 240605-BLXT-HBE
Conditions: Epilepsy (treatment Refractory)
Keywords: crossover, bioequivalence, Brivaracetam Oral Solution
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study start: 21 Oct 2024 (actual)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 8 Jan 2025 (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.

The main questions it aims to answer are:

Do the test and reference formulations of Brivaracetam oral solution exhibit similar pharmacokinetic behavior in the body?
What are the clinical safety outcomes for participants taking the test and reference formulations?

Participants will:

Cross over to the alternate formulation after a 7-day washout period, completing a total of two treatment periods (2 weeks).

Undergo regular checkups and tests to monitor pharmacokinetics and safety outcomes.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: A two-period, two-sequence crossover design where participants are randomly assigned to receive either the test or reference formulation in a fasted or fed state, with a washout period of seven days between treatments.

Arm	Type	Receives
Fasting group	Experimental	Drug: Brivaracetam Oral Solution (Test Formulation), Drug: Brivaracetam Oral Solution (Reference Formulation)Participants in fasting group will first receive a single oral dose of the test formulation of Brivaracetam oral solution in the first period, followed by a washout period, and then a single oral dose of the reference formulation of Brivaracetam oral solution in the second period.
High-fat meal group	Experimental	Drug: Brivaracetam Oral Solution (Test Formulation), Drug: Brivaracetam Oral Solution (Reference Formulation)Participants will first receive a single oral dose of the reference formulation of Brivaracetam oral solution in the first period, followed by a washout period, and then a single oral dose of the test formulation of Brivaracetam in the second period.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age and Gender: Healthy male and female participants aged 18-55 years (inclusive).
Weight and BMI: Male participants must weigh ≥50 kg, and females ≥45 kg, with a body mass index (BMI) between 19 and 26. BMI is calculated as: BMI = weight (kg) / height (m²).
Participants must fully understand the purpose, methods, content, and test drugs of this study before enrollment, be capable of good communication with investigators, adhere to study requirements, and voluntarily sign the informed consent form.
Participants must commit to avoiding pregnancy and refraining from sperm/egg donation from the time of consent through 3 months after the last dose. Participants must agree to use effective contraception (non-pharmacological methods) during the trial. Female participants must have had no unprotected sexual activity within 14 days before the first dose.

Key exclusion criteria (20 listed)

History of allergies (e.g., angioedema, anaphylactic shock) or hypersensitivity (e.g., to pollen, two or more drugs/foods), or known allergy to briciclib or its excipients.
Past or current illnesses that may affect drug absorption, distribution, metabolism, excretion, or the interpretation of safety data, or conditions reducing compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, oncological, immunological, psychiatric, or cardiovascular diseases, as judged by the investigator.
Major surgery within 3 months prior to screening or planned surgery during the study period, including procedures affecting pharmacokinetics (e.g., gallbladder/biliary tract surgery).
History of significant bleeding, active bleeding, thrombocytopenia, coagulation disorders, or family history of coagulopathy.
Vaccination within 28 days prior to screening or planned vaccination during the study.

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
Brivaracetam Oral Solution (Test Formulation)The drug is manufactured by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.	Drug	Fasting group, High-fat meal group
Brivaracetam Oral Solution (Reference Formulation)Also: Briviact®The drug is manufactured by UCB Pharma S.A. under the trade name Briviact®. The formulation is provided as a 300 mL: 3 g solution, with a dosage of 10 mL (100 mg) per single oral dose. The drug will be administered to participants in the fasting group during the first phase of the study and to participants in the high-fat meal group during the second phase of the study.	Drug	Fasting group, High-fat meal group

Primary outcome

Maximum Plasma Concentration (Cmax)
Time frame: two weeks
Cmax is the maximum observed plasma concentration of the drug following a single oral dose. This parameter reflects the peak exposure to the drug in the bloodstream after administration.
Area Under the Plasma Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-t)
Time frame: two weeks
AUC0-t represents the total drug exposure from time 0 to the last measurable concentration. It is an important pharmacokinetic parameter for understanding the extent of drug absorption over time.
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞)
Time frame: two weeks
AUC0-∞ is the area under the plasma concentration-time curve from time 0 to infinity, capturing the total exposure to the drug. It includes all measurable concentrations, both during and after the absorption phase.

4 secondary outcomes

Time to Reach Maximum Plasma Concentration(Tmax )
Time frame: two weeks
Terminal Elimination Rate Constant (λz)
Time frame: two weeks
Half-life (t1/2)
Time frame: two weeks
Percentage of the Area Under the Curve Extrapolated to Infinity(AUC_%Extrap )
Time frame: two weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Background: PubMed 29017941Velazquez J, Acosta J, Herrera N, Morales A, Gonzalez O, Herrera F, Estrada MP, Carpio Y. Novel IFNgamma homologue identified in Nile tilapia (Oreochromis niloticus) links with immune response in gills under different stimuli. Fish Shellfish Immunol. 2017 Dec;71:275-285. doi: 10.1016/j.fsi.2017.10.014. Epub 2017 Oct 7.
Background: PubMed 23414556Aranake A, Mashour GA, Avidan MS. Minimum alveolar concentration: ongoing relevance and clinical utility. Anaesthesia. 2013 May;68(5):512-22. doi: 10.1111/anae.12168. Epub 2013 Feb 16.
Background: PubMed 29017947Cho SY, Kwon YK, Nam M, Vaidya B, Kim SR, Lee S, Kwon J, Kim D, Hwang GS. Integrated profiling of global metabolomic and transcriptomic responses to viral hemorrhagic septicemia virus infection in olive flounder. Fish Shellfish Immunol. 2017 Dec;71:220-229. doi: 10.1016/j.fsi.2017.10.007. Epub 2017 Oct 7.
Background: PubMed 23874156Tsilidis KK, Panagiotou OA, Sena ES, Aretouli E, Evangelou E, Howells DW, Al-Shahi Salman R, Macleod MR, Ioannidis JP. Evaluation of excess significance bias in animal studies of neurological diseases. PLoS Biol. 2013 Jul;11(7):e1001609. doi: 10.1371/journal.pbio.1001609. Epub 2013 Jul 16.
Background: PubMed 35794358Zhu M, Tao Y, Pu J, Zhao H, Wan L, Zhang P, Tang C. Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4-Way Replicate Crossover Study. Clin Pharmacol Drug Dev. 2023 Jan;12(1):30-37. doi: 10.1002/cpdd.1137. Epub 2022 Jul 6.
the protocol of the studyLink provided by the sponsor.
Individual participant dataSharing planned: Yes

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 20 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) (time frame: two weeks). 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?

On the ClinicalTrials.gov record for NCT06762743, which also lists 5 linked publications.

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 8 Jan 2025.