Bioequivalence Study in Healthy Subjects
Conditions
Brief 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. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation.
Interventions
DRUGBriveka ® 100 mg
Brivaracetam coated tablets
DRUGBriviact® 100 mg
Brivaracetam coated tablets
Sponsors
Zodiac Produtos Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to 48 hours after drug administration | Maximum observed plasma concentration of brivaracetam following a single-dose. |
| AUC0-t | Up to 48 hours after drug administration | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of brivaracetam. |
Countries
Brazil
Outcome results
None listed