Can a copycat epilepsy drug match the original? a trial puts it to the test
NCT ID NCT07800533
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This Phase 1 trial checks whether a new coated tablet containing brivaracetam delivers the same amount of the drug into the bloodstream as the reference product Briviact. Researchers give a single dose of each version to 28 healthy adults under fasting conditions and compare key measures like peak concentration and total exposure. The goal is to see if the two formulations are bioequivalent, meaning they behave alike in the body. If they do, the test tablet could serve as a generic alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brivaracetam
- What this could lead to
- If the test tablet proves equivalent, it could become a lower-cost generic alternative to Briviact for people who need brivaracetam.
- What could go wrong
- This is a small early-stage study in healthy volunteers, not patients. Even if the tablets match, regulators must still approve the generic, and results may not predict effects in people with epilepsy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
28 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
-
Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Unidade Integrada de Farmacologia e Gastroenterologia (UNIFAG)
Bragança Paulista, São Paulo, 12916-900, Brazil
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