Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects

NCT07393022 | Completed Phase 1

• 1 other identifier: LEV-004/K
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetic Analysis; Bioequivalence; Health Adult Subjects

Keywords

single dose; randomized; bioequivalence; two-period; crossover; levetiracetam

Outcome Measures

Primary Outcomes (2)

• Bioequivalence between Levetiracetam Desitin 1500 mg coated granules and Keppra

  Bioequivalence is concluded under fasting conditions if the 90% confidence interval for the Test/Reference ratios of geometric means for AUCt and Cmax are contained within the ICH-defined acceptance range of 80-125% for levetiracetam

  From enrollment to the end of clinical phase at 2 weeks

• AUC

  Area under Curve

  From enrollment to the end of the study at 1 week

Study Arms (2)

Levetiracetam 1500 mg

EXPERIMENTAL

Levetiracetam 1500 mg coated granules, single oral dose

Drug: Levetiracetam 1500 mg

Keppra 750 mg

ACTIVE COMPARATOR

Keppra 750 mg film-coated tablets, single oral dose of two tablets

Drug: Keppra® 750 mg

Interventions

Levetiracetam 1500 mg DRUG

coated granules, single oral dose

Levetiracetam 1500 mg

Keppra® 750 mg DRUG

single oral dose of two tablets

Keppra 750 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
• Agree not to have a tattoo or body piercing until the end of the study.
• Agree not to drive or operate heavy machinery if feeling dizzy or drowsy following study drug administration until full mental alertness is regained.
• Female participants must fulfill at least one of the following:
• Be surgically sterile for a minimum of 6 months (achieved through partial or total hysterectomy, bilateral oophorectomy, bilateral tubal ligation or bilateral salpingectomy); BPSI Protocol Number: 2953 Sponsor Protocol Number: LEV-004/K Protocol Version Number: 1.0, Dated: Oct-14-2025 Levetiracetam 1500 mg coated granules in sachet formulations Fasting Conditions Page 19 of 51
• Post-menopausal for a minimum of 1 year (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause), confirmed by FSH test;
• Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).

You may not qualify if:

• 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:
• Alcohol abuse or dependence within one year prior to first study drug administration;
• Drug abuse or dependence;
• Significant reaction (allergic, anaphylactic, hypersensitivity, angioedema) or severe response to levetiracetam, their excipients and to any other drug or food unless deemed by the PI/Sub-I as "Not Clinically Significant.";
• Stevens-Johnson syndrome (SJS);
• Toxic Epidermal Necrolysis (TEN);
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS);
• Seizure associated with a particular genetic mutation called SCN8A mutation; BPSI Protocol Number: 2953 Sponsor Protocol Number: LEV-004/K Protocol Version Number: 1.0, Dated: Oct-14-2025 Levetiracetam 1500 mg coated granules in sachet formulations Fasting Conditions Page 21 of 51
• Suicidal ideation, attempts and/or behaviour, as assessed by the C-SSRS (baseline version) - Appendix B;

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead

Study Sites (1)

Biopharma Services Inc.

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, 2-period, open-label

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 6, 2026
• Study Start: December 17, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)