Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects (NCT07393022) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects
Canada20 participantsStarted 2025-12-17
Plain-language summary
Pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover, bioequivalence study of Levetiracetam 1500 mg coated granules in sachet formulations and Keppra (Levetiracetam) 2 x 750 mg film-coated tablet formulations in healthy male and female under fasting conditions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy, non-smoking (for at least 6 months prior to first drug administration) male and non-pregnant female volunteers, 18 years of age and older, inclusive.
. BMI that is between 18.5-30.0 kg/m², inclusive.
. Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
. QTc interval ≤ 450 milliseconds for males and ≤ 470 milliseconds for females, unless deemed otherwise by the PI/Sub-Investigator.
. Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
. Clinical laboratory values within BPSI's most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bioequivalence between Levetiracetam Desitin 1500 mg coated granules and Keppra
Timeframe: From enrollment to the end of clinical phase at 2 weeks
2
AUC
Timeframe: From enrollment to the end of the study at 1 week
. Ability to comprehend and be informed of the nature of the study, as assessed by BPSI staff. Capable of giving written informed consent prior to any study- related procedure. Must be able to communicate effectively with clinic staff.
. Ability to fast for at least 14 hours and consume standard meals.
Exclusion criteria
. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
. Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
. Estimated creatinine clearance \<60 ml/min, unless determined as not clinically significant by the PI/Sub-Investigator.
. Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
. Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
. A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), breath alcohol test and cotinine. Positive pregnancy test for female participants.
. Known history or presence of:
. Intolerance to and/or difficulty with blood sampling through venipuncture.