Partial SeizurePhase 1NCT05622370
An Open Label, Balanced, Randomized, 3×3 Latin Square Design Comparing of Brivaracetam Sustained-release Tablets and Brivaracetam Tablets in the Oral Comparative Pharmacokinetic(PK) Study in Chinese Healthy Adult Subjects Under Fasting Conditions.
A Phase 1 study testing Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB), Brivaracetam sustained-release tablets 100mg and Brivaracetam sustained-release tablets 50mg in people with Partial Seizure, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
An open label, balanced, randomized, 3×3 latin square design comparing of Brivaracetam sustained-release tablets and Brivaracetam tablets in the oral comparative pharmacokinetic(PK) study in Chinese healthy adult subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Seizure
- What is being tested?
- Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB), Brivaracetam sustained-release tablets 100mg and Brivaracetam sustained-release tablets 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2022to 30 Mar 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, volunteer as subjects, and sign an informed consent form before any research procedure starts;
- Male and female subjects aged from 18 to 60 years (including 18 and 60 years);
- Male weight ≥50.0 kg, female weight ≥45.0 kg, body mass index (BMI) in the range of 19.0~26.0 kg/m2 (including the critical value);
- The subject has no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal system, etc., and is in good general health;
- During screening, vital signs examination, physical examination, clinical laboratory examination (blood routine examination, urine routine examination, blood biochemistry examination, hepatitis B, hepatitis C, AIDS and syphilis examination, coagulation function), pregnancy examination (only for women), chest X-ray examination, 12-lead electrocardiogram and nicotine examination, the results show that there is no abnormality or no clinical significance;
- Subjects (including male subjects) have no pregnancy plans and voluntarily take effective contraceptive measures from two weeks before the screening date to six months after the last administration, and have no plans for sperm donation or egg donation; Female subjects/male subjects and their female partners of childbearing age did not have unprotected sex within one month before the screening, and female subjects agreed not to use contraceptives from the screening to the end of the trial;
- Subjects can communicate well with researchers, and understand and abide by the requirements of this research.
Who cannot join
- those who have a history of allergy to research drugs or their adjuvants, or are allergic to drugs, food, pollen or have a specific history of allergy (asthma, allergic rhinitis, eczema), etc.;
- Have a history of dysphagia or any gastrointestinal diseases that affect drug absorption;
- Anyone who has a history of surgery or trauma that may affect the safety of the trial or the in vivo process of the drug, or who plans to have surgery during the study period;
- Any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products were taken orally within 28 days before the screening, especially any drugs that change the activity of liver enzymes (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; Inhibitors--SSRI antidepressants, cimetidine, diltiazem macrocyclic lipids, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc.);
- Screening those who have a history of drug abuse within 6 months before;
- Screening those who have used drugs within the first 3 months;
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- Screening those who have been vaccinated within 2 months before screening;
- Those who smoke more than 5 cigarettes per day within 3 months before screening, or can't stop using any tobacco products during the trial period;
- Drinking more than 14 units per week (1 unit = 17.7 mL of ethanol, that is, 1 unit = 357 mL of 5% alcohol beer or 43 mL of 40% alcohol liquor or 147 mL of 12% alcohol wine) within 3 months before screening, or those who can't abstain from drinking during the experiment;
- Those who drink excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day within 3 months before screening;
- those who have participated in other drug clinical trials within 3 months before administration or who have not participated in clinical trials by themselves;
- Blood donation within 3 months before screening includes blood component or massive blood loss (≥450mL), and those who receive blood transfusion or use blood products are planned to donate blood during the test period;
- The subject (female) is in lactation;
- Those who can't tolerate venipuncture and have a history of fainting from needles and blood;
- Those who have special requirements for diet and cannot accept a unified diet;
- Screening those who have had significantly abnormal diet (such as dieting and low sodium) within 1 month before screening;
- Subjects judged by other researchers to be unsuitable for participation
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Municipal People's Hospital
Tianjin, Tianjin Municipality, 300121
About this study
An open label, balanced, randomized, 3×3 latin square design comparing of Brivaracetam sustained-release tablets and Brivaracetam tablets in the oral comparative pharmacokinetic(PK) study in Chinese healthy adult subjects under fasting conditions.
Test preparation A(T1): Brivaracetam sustained-release tablets (100mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Test preparation B(T2): Brivaracetam sustained-release tablets (50mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Reference preparation (R): Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) Objective: The sustained-release tablets of Brivaracetam (specification: 100mg) developed by Taizhou Overseas Pharmaceuticals Co.,Ltd. were used as the test preparation A(T1), the sustained-release tablets of Brivaracetam (specification: 50mg) were used as the test preparation B(T2), and the Brivaracetam tablets (trade name: BRIVIACT®, specification: 50mg) produced by UCB were used as the reference preparation (R). To compare the blood concentration and main pharmacokinetic parameters between test preparation A(T1) and test preparation B(T2), between test preparation A(T1) and reference preparation, and between test preparation B(T2) and reference preparation, and evaluate the relative bioavailability and sustained release characteristics of test preparation.
Objective: To evaluate the safety of China healthy volunteers after oral administration of sustained-release tablets of test preparation A(T1) and B(T2) and reference preparation (R) Brivaracetam tablets on an empty stomach.
Read the detailed description
Single-center, randomized, open, 3×3 Latin square design, and administration on an empty stomach. All subjects must sign an informed consent form before taking part in the trial. 12 healthy subjects (half male and half female) who passed the screening were randomly divided into three groups: T1-T2-R group, T2-R-T1 group and R-T1-T2 group, with 4 people in each group. The selected subjects entered the first ward of the clinical research center one day before taking medicine in each cycle, and fasted for more than 10 hours before taking medicine in each cycle.
On the morning of taking medicine in each cycle, after the collection of blank blood samples, the corresponding study drugs were taken according to the random table, and 240mL of warm water was taken. Eat standard lunch after 4h of the first administration, eat standard dinner after 10h, and drink water before and within 1h after the first administration (except 240mL of water used for administration). During the experiment, a unified diet is required. The test method is the same for each cycle, and the cleaning period for each cycle is 7 days.
PK blood collection and blood sample treatment:
For test preparation A(T1) and test preparation B(T2):
Before administration (0h) and 5min、10min、20min、40min、1h、1.25h、1.5h、1.75h、2h、2.5h、3h、3.5h、4h、4.5h、5h、5.5h、6h、7h、8h、10h、12h、16h、24h、36h、48h,Blood samples were collected at 26 time points.
For the reference preparation (R):
Before (0h) and after 5min、10min、20min、40min、1h、1.25h、1.5h、1.75h、2h、2.25h、2.5h、3h、4h、6h、8h、10h、12h、12.25h、12.5h、12.75h、13h、13.25h、13.5h、13.75h、14h、14.5h、15h、16h、18h、24h、36h、48h，Blood samples were collected at 33 time points.
The sitting vital signs (including body temperature, pulse and blood pressure) of the subjects were measured within 1 hour before the first administration and 2.0h±0.5h, 4.0h±0.5h, 24±1.0h and 48±1.0h after administration. In the third cycle, the subjects were examined for safety before leaving the hospital, including physical examination, vital signs examination, electrocardiogram and laboratory related examination. During the study, pay attention to observe and ask the subjects' subjective feelings and possible adverse events during the experiment. All the subjects were followed up by telephone or WeChat 7~10 days after the end of the third cycle, and asked if there were any follow-up adverse events. In case of AE, AE should be recorded and followed up.
If AE occurs during the trial, it needs to be followed up until the AE returns to normal or stable state or abnormal, which has no clinical significance or is lost.
- Conditions
- Partial Seizure
- Being tested
- Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB), Brivaracetam sustained-release tablets 100mg, Brivaracetam sustained-release tablets 50mg
- Keywords
- Epilepsy, 16 years old and above, brivaracetam
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB)Drug
Brivaracetam tablets (trade name: Briviact) Specification: 50mg/ piece Batch number: 34244 Content: 100.0% Date of purchase: September 2022
According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach.
Expiry date: April 2025 Storage conditions: sealed, stored at 20-25℃, allowing short-term temperature deviation of 15-30℃ Manufacturer: Union Chimique Belge Pharm, UCB Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd.
Brivaracetam sustained-release tablets 100mgDrug
Brivaracetam sustained-release tablets Specification: 100mg/ tablet Batch number: 22081201 Content: 102.5% Date of production: August 12, 2022 Expiry date: August 11th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd.
According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach.
Brivaracetam sustained-release tablets 50mgDrug
Brivaracetam sustained-release tablets Specification: 50mg/ piece Batch number: 22082501 Content: 100.0% Date of production: September 02, 2022 Expiry date: August 24th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd.
According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam sustained-release tablets 100mg | Experimental | Brivaracetam sustained-release tablets Specification: 100mg/ tablet Batch number: 22081201 Content: 102.5% Date of production: August 12, 2022 Expiry date: August 11th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd.
According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. Receives: Drug: Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB); Drug: Brivaracetam sustained-release tablets 50mg |
| Brivaracetam sustained-release tablets 50mg | Experimental | Brivaracetam sustained-release tablets Specification: 50mg/ piece Batch number: 22082501 Content: 100.0% Date of production: September 02, 2022 Expiry date: August 24th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd.
According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. Receives: Drug: Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB); Drug: Brivaracetam sustained-release tablets 100mg |
| Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) | Active comparator | Brivaracetam tablets (trade name: Briviact) Specification: 50mg/ piece Batch number: 34244 Content: 100.0% Date of purchase: September 2022
According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach.
Expiry date: April 2025 Storage conditions: sealed, stored at 20-25℃, allowing short-term temperature deviation of 15-30℃ Manufacturer: Union Chimique Belge Pharm, UCB Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd. Receives: Drug: Brivaracetam sustained-release tablets 100mg; Drug: Brivaracetam sustained-release tablets 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Area under the curve from time zero to infinity (AUC0-inf)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Peak concentration at each treatment period (Cmax,tp)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Secondary outcomes (4)
Peak concentration of the first dosing (Cmax)
Individual Brivaracetam plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Time to reach peak concentration of the first dosing (Tmax)
Individual brivaracetam plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Terminal half-life (T1/2)
Individual brivaracetam plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Mean residence time (MRT)
Individual brivaracetam plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start13 Sep 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial SeizureStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Test preparation A(T1): Brivaracetam sustained-release tablets (100mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Test preparation B(T2): Brivaracetam sustained-release tablets (50mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Reference preparation (R): Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GX pharma technology (beijing) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622370
- Sponsor's protocol ID
- GXPH-BLXTHSP-YPK
- Status last verified
- Nov 2022
- First submitted
- 11 Nov 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, 3×3 Latin Square Design Comparing of Brivaracetam Sustained-release Tablets and Brivaracetam Tablets in the Oral Comparative Pharmacokinetic(PK) Study in Chinese Healthy Adult Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT05622370
- Acronym / sponsor ID
- GXPH-BLXTHSP-YPK
- Conditions
- Partial Seizure
- Keywords
- Epilepsy, 16 years old and above, brivaracetam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- GX pharma technology (beijing) Co., Ltd
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 18 Nov 2022 (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.
An open label, balanced, randomized, 3×3 latin square design comparing of Brivaracetam sustained-release tablets and Brivaracetam tablets in the oral comparative pharmacokinetic(PK) study in Chinese healthy adult subjects under fasting conditions.
Test preparation A(T1): Brivaracetam sustained-release tablets (100mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Test preparation B(T2): Brivaracetam sustained-release tablets (50mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Reference preparation (R): Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) Objective: The sustained-release tablets of Brivaracetam (specification: 100mg) developed by Taizhou Overseas Pharmaceuticals Co.,Ltd. were used as the test preparation A(T1), the sustained-release tablets of Brivaracetam (specification: 50mg) were used as the test preparation B(T2), and the Brivaracetam tablets (trade name: BRIVIACT®, specification: 50mg) produced by UCB were used as the reference preparation (R). To compare the blood concentration and main pharmacokinetic parameters between test preparation A(T1) and test preparation B(T2), between test preparation A(T1) and reference preparation, and between test preparation B(T2) and reference preparation, and evaluate the relative bioavailability and sustained release characteristics of test preparation.
Objective: To evaluate the safety of China healthy volunteers after oral administration of sustained-release tablets of test preparation A(T1) and B(T2) and reference preparation (R) Brivaracetam tablets on an empty stomach.
Detailed description
Single-center, randomized, open, 3×3 Latin square design, and administration on an empty stomach. All subjects must sign an informed consent form before taking part in the trial. 12 healthy subjects (half male and half female) who passed the screening were randomly divided into three groups: T1-T2-R group, T2-R-T1 group and R-T1-T2 group, with 4 people in each group. The selected subjects entered the first ward of the clinical research center one day before taking medicine in each cycle, and fasted for more than 10 hours before taking medicine in each cycle.
On the morning of taking medicine in each cycle, after the collection of blank blood samples, the corresponding study drugs were taken according to the random table, and 240mL of warm water was taken. Eat standard lunch after 4h of the first administration, eat standard dinner after 10h, and drink water before and within 1h after the first administration (except 240mL of water used for administration). During the experiment, a unified diet is required. The test method is the same for each cycle, and the cleaning period for each cycle is 7 days.
PK blood collection and blood sample treatment:
For test preparation A(T1) and test preparation B(T2):
Before administration (0h) and 5min、10min、20min、40min、1h、1.25h、1.5h、1.75h、2h、2.5h、3h、3.5h、4h、4.5h、5h、5.5h、6h、7h、8h、10h、12h、16h、24h、36h、48h,Blood samples were collected at 26 time points.
For the reference preparation (R):
Before (0h) and after 5min、10min、20min、40min、1h、1.25h、1.5h、1.75h、2h、2.25h、2.5h、3h、4h、6h、8h、10h、12h、12.25h、12.5h、12.75h、13h、13.25h、13.5h、13.75h、14h、14.5h、15h、16h、18h、24h、36h、48h，Blood samples were collected at 33 time points.
The sitting vital signs (including body temperature, pulse and blood pressure) of the subjects were measured within 1 hour before the first administration and 2.0h±0.5h, 4.0h±0.5h, 24±1.0h and 48±1.0h after administration. In the third cycle, the subjects were examined for safety before leaving the hospital, including physical examination, vital signs examination, electrocardiogram and laboratory related examination. During the study, pay attention to observe and ask the subjects' subjective feelings and possible adverse events during the experiment. All the subjects were followed up by telephone or WeChat 7~10 days after the end of the third cycle, and asked if there were any follow-up adverse events. In case of AE, AE should be recorded and followed up.
If AE occurs during the trial, it needs to be followed up until the AE returns to normal or stable state or abnormal, which has no clinical significance or is lost.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Test preparation A(T1): Brivaracetam sustained-release tablets (100mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Test preparation B(T2): Brivaracetam sustained-release tablets (50mg/ tablet, developed by Taizhou Overseas Pharmaceuticals Co.,Ltd.) Reference preparation (R): Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB)
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam sustained-release tablets 100mg | Experimental | Drug: Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB), Drug: Brivaracetam sustained-release tablets 50mgBrivaracetam sustained-release tablets Specification: 100mg/ tablet Batch number: 22081201 Content: 102.5% Date of production: August 12, 2022 Expiry date: August 11th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd. According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. |
| Brivaracetam sustained-release tablets 50mg | Experimental | Drug: Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB), Drug: Brivaracetam sustained-release tablets 100mgBrivaracetam sustained-release tablets Specification: 50mg/ piece Batch number: 22082501 Content: 100.0% Date of production: September 02, 2022 Expiry date: August 24th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd. According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. |
| Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) | Active comparator | Drug: Brivaracetam sustained-release tablets 100mg, Drug: Brivaracetam sustained-release tablets 50mgBrivaracetam tablets (trade name: Briviact) Specification: 50mg/ piece Batch number: 34244 Content: 100.0% Date of purchase: September 2022 According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. Expiry date: April 2025 Storage conditions: sealed, stored at 20-25℃, allowing short-term temperature deviation of 15-30℃ Manufacturer: Union Chimique Belge Pharm, UCB Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, volunteer as subjects, and sign an informed consent form before any research procedure starts;
- Male and female subjects aged from 18 to 60 years (including 18 and 60 years);
- Male weight ≥50.0 kg, female weight ≥45.0 kg, body mass index (BMI) in the range of 19.0~26.0 kg/m2 (including the critical value);
- The subject has no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal system, etc., and is in good general health;
- During screening, vital signs examination, physical examination, clinical laboratory examination (blood routine examination, urine routine examination, blood biochemistry examination, hepatitis B, hepatitis C, AIDS and syphilis examination, coagulation function), pregnancy examination (only for women), chest X-ray examination, 12-lead electrocardiogram and nicotine examination, the results show that there is no abnormality or no clinical significance;
Key exclusion criteria (17 listed)
- those who have a history of allergy to research drugs or their adjuvants, or are allergic to drugs, food, pollen or have a specific history of allergy (asthma, allergic rhinitis, eczema), etc.;
- Have a history of dysphagia or any gastrointestinal diseases that affect drug absorption;
- Anyone who has a history of surgery or trauma that may affect the safety of the trial or the in vivo process of the drug, or who plans to have surgery during the study period;
- Any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products were taken orally within 28 days before the screening, especially any drugs that change the activity of liver enzymes (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; Inhibitors--SSRI antidepressants, cimetidine, diltiazem macrocyclic lipids, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc.);
- Screening those who have a history of drug abuse within 6 months before;
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 tablets (50mg/ tablet, BRIVIACT®, UCB)Brivaracetam tablets (trade name: Briviact) Specification: 50mg/ piece Batch number: 34244 Content: 100.0% Date of purchase: September 2022 According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. Expiry date: April 2025 Storage conditions: sealed, stored at 20-25℃, allowing short-term temperature deviation of 15-30℃ Manufacturer: Union Chimique Belge Pharm, UCB Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd. | Drug | Brivaracetam sustained-release tablets 100mg, Brivaracetam sustained-release tablets 50mg |
| Brivaracetam sustained-release tablets 100mgBrivaracetam sustained-release tablets Specification: 100mg/ tablet Batch number: 22081201 Content: 102.5% Date of production: August 12, 2022 Expiry date: August 11th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd. According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. | Drug | Brivaracetam sustained-release tablets 50mg, Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) |
| Brivaracetam sustained-release tablets 50mgBrivaracetam sustained-release tablets Specification: 50mg/ piece Batch number: 22082501 Content: 100.0% Date of production: September 02, 2022 Expiry date: August 24th, 2024. Storage conditions: sealed and stored at 10-30℃ Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Taizhou Overseas Pharmaceuticals Co.,Ltd. According to the random table, take test preparation A(T1) once (1 tablet/time) or test preparation B(T2) once (2 tablets/time) or reference preparation (R) twice (1 tablet/time, with an interval of 12 hours, before taking the medicine for the first time) on an empty stomach. | Drug | Brivaracetam sustained-release tablets 100mg, Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB) |
Primary outcome
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Area under the curve from time zero to infinity (AUC0-inf)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Peak concentration at each treatment period (Cmax,tp)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within [0.8, 1.25] range will be used to determine the result of bioequivalence.
4 secondary outcomes
Peak concentration of the first dosing (Cmax)
Time frame: 1 month
Time to reach peak concentration of the first dosing (Tmax)
Time frame: 1 month
Terminal half-life (T1/2)
Time frame: 1 month
Mean residence time (MRT)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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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?
A Phase 1 study testing Brivaracetam tablets (50mg/ tablet, BRIVIACT®, UCB), Brivaracetam sustained-release tablets 100mg and Brivaracetam sustained-release tablets 50mg in people with Partial Seizure, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
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 7 inclusion and 17 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 1 Feb 2023. 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?
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last) (time frame: 1 month). 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 1 Feb 2023; AzTrials last refreshed its copy on 29 Oct 2026.