Bioequivalence Study in Healthy SubjectsPhase 1NCT07800533
Brivaracetam Bioequivalence Assessment
A Phase 1 study testing Briveka ® 100 mg and Briviact® 100 mg in people with Bioequivalence Study in Healthy Subjects, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
This study assess the relative bioavailability performance of a test brivaracetam coated tablets compared with the EMA reference product, Briviact® 100 mg, in healthy adult volunteers of both sexes under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study in Healthy Subjects
- What is being tested?
- Briveka ® 100 mg and Briviact® 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Aug 2024to 19 Aug 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 30.0 kg/m². Non-smokers or former smokers who stopped smoking at least 1 year prior to screening.
- Clinically healthy based on medical history, physical examination, vital signs, ECG, and clinical laboratory tests.
- Negative screening for HIV, hepatitis B, and hepatitis C. Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test.
- No hair, wounds, or dermatological conditions at the intended patch application site (upper arm).
- Able to understand the study procedures and provide written informed consent
Who cannot join
- History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic, pulmonary, or dermatological diseases.
- Known hypersensitivity to rivastigmine, carbamate derivatives, or any component of the study formulation.
- Abnormal clinical laboratory results, vital signs, or ECG considered clinically significant by the investigator.
- Positive test results for drugs of abuse, alcohol misuse, HIV, hepatitis B, or hepatitis C.
- Use of prescription or non-prescription medications that could interfere with the study drug within a defined period prior to dosing, as determined by the investigator.
- Participation in another clinical trial or exposure to an investigational drug within the previous 6 months.
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- Blood donation or significant blood loss within 3 months prior to the study.
- Consumption of grapefruit-containing products, alcohol, or substances that could interfere with drug metabolism prior to dosing.
- Use of medications known to significantly affect hepatic metabolism.
- Positive or suspected infection with SARS-CoV-2 prior to study periods.
- Any condition that, in the investigator's judgment, could interfere with study participation or the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unidade Integrada de Farmacologia e Gastroenterologia (UNIFAG)
Bragança Paulista, São Paulo, 12916-900
About this study
Official title: Bioequivalence Assessment Between Two Brivaracetam 100 mg Coated Tablet Formulations
This study assess the relative bioavailability performance of a test brivaracetam coated tablets compared with the EMA reference product, Briviact® 100 mg, in healthy adult volunteers of both sexes under fasting conditions. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation.
- Conditions
- Bioequivalence Study in Healthy Subjects
- Being tested
- Briveka ® 100 mg, Briviact® 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Briveka ® 100 mgDrug
Also called Test
Brivaracetam coated tablets
Briviact® 100 mgDrug
Also called Comparator
Brivaracetam coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Single oral dose administration of the test formulation Briveka® (brivaracetam coated tablets) 100 mg Receives: Drug: Briveka ® 100 mg |
| Comparator | Active comparator | Single oral dose administration of the reference formulation Briviact® (brivaracetam coated tablets) 100 mg Receives: Drug: Briviact® 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration of brivaracetam following a single-dose.
Measured: Up to 48 hours after drug administration
AUC0-t
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of brivaracetam.
Measured: Up to 48 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start9 Aug 2024
- Primary completion16 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bioequivalence Study in Healthy SubjectsStudies 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800533
- Sponsor's protocol ID
- CNSP2024
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to confidentiality restrictions and institutional policies regarding participant-level clinical data.
Publications
Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19.
PubMed 22813235Sargentini-Maier ML, Rolan P, Connell J, Tytgat D, Jacobs T, Pigeolet E, Riethuisen JM, Stockis A. The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after single increasing oral doses in healthy males. Br J Clin Pharmacol. 2007 Jun;63(6):680-8. doi: 10.1111/j.1365-2125.2006.02829.x. Epub 2007 Jan 12.
PubMed 17223857Otoul C, Watanabe S, McCabe S, Stockis A. Relative Bioavailability and Bioequivalence of Brivaracetam 10 mg/mL Oral Solution and 50-mg Film-Coated Tablet. Clin Pharmacol Drug Dev. 2017 May;6(3):313-317. doi: 10.1002/cpdd.275. Epub 2016 Jun 28. No abstract available.
PubMed 27274002
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Assessment Between Two Brivaracetam 100 mg Coated Tablet Formulations
- ClinicalTrials.gov ID
- NCT07800533
- Acronym / sponsor ID
- CNSP2024
- Conditions
- Bioequivalence Study in Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 2 Sep 2026 (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.
This study assess the relative bioavailability performance of a test brivaracetam coated tablets compared with the EMA reference product, Briviact® 100 mg, in healthy adult volunteers of both sexes under fasting conditions. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Briveka ® 100 mgSingle oral dose administration of the test formulation Briveka® (brivaracetam coated tablets) 100 mg |
| Comparator | Active comparator | Drug: Briviact® 100 mgSingle oral dose administration of the reference formulation Briviact® (brivaracetam coated tablets) 100 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 18.5 and 30.0 kg/m². Non-smokers or former smokers who stopped smoking at least 1 year prior to screening.
- Clinically healthy based on medical history, physical examination, vital signs, ECG, and clinical laboratory tests.
- Negative screening for HIV, hepatitis B, and hepatitis C. Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test.
- No hair, wounds, or dermatological conditions at the intended patch application site (upper arm).
- Able to understand the study procedures and provide written informed consent
Key exclusion criteria (11 listed)
- History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic, pulmonary, or dermatological diseases.
- Known hypersensitivity to rivastigmine, carbamate derivatives, or any component of the study formulation.
- Abnormal clinical laboratory results, vital signs, or ECG considered clinically significant by the investigator.
- Positive test results for drugs of abuse, alcohol misuse, HIV, hepatitis B, or hepatitis C.
- Use of prescription or non-prescription medications that could interfere with the study drug within a defined period prior to dosing, as determined by the investigator.
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 |
|---|---|---|
| Briveka ® 100 mgAlso: TestBrivaracetam coated tablets | Drug | Test |
| Briviact® 100 mgAlso: ComparatorBrivaracetam coated tablets | Drug | Comparator |
Primary outcome
Cmax
Time frame: Up to 48 hours after drug administration
Maximum observed plasma concentration of brivaracetam following a single-dose.
AUC0-t
Time frame: Up to 48 hours after drug administration
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of brivaracetam.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 22813235Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19.
- Background: PubMed 17223857Sargentini-Maier ML, Rolan P, Connell J, Tytgat D, Jacobs T, Pigeolet E, Riethuisen JM, Stockis A. The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after single increasing oral doses in healthy males. Br J Clin Pharmacol. 2007 Jun;63(6):680-8. doi: 10.1111/j.1365-2125.2006.02829.x. Epub 2007 Jan 12.
- Background: PubMed 27274002Otoul C, Watanabe S, McCabe S, Stockis A. Relative Bioavailability and Bioequivalence of Brivaracetam 10 mg/mL Oral Solution and 50-mg Film-Coated Tablet. Clin Pharmacol Drug Dev. 2017 May;6(3):313-317. doi: 10.1002/cpdd.275. Epub 2016 Jun 28. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to confidentiality restrictions and institutional policies regarding participant-level clinical data.
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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 Briveka ® 100 mg and Briviact® 100 mg in people with Bioequivalence Study in Healthy Subjects, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 2 Sep 2026. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax (time frame: Up to 48 hours after drug administration). The study lists 2 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 NCT07800533, which also lists 3 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 2 Sep 2026.