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 range18 Years
SexALL
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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".
✓. 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.
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
✕. 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.