Pharmacokinetic AnalysisPhase 1NCT07393022
Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects
A Phase 1 study testing Levetiracetam 1500 mg and Keppra® 750 mg in people with Pharmacokinetic Analysis and Bioequivalence, run by Desitin Arzneimittel GmbH at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Analysis, Bioequivalence, Health Adult Subjects
- What is being tested?
- Levetiracetam 1500 mg and Keppra® 750 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2025to 5 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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".
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- 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).
Who cannot join
- 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.
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- 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;
- Presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant".
- Intolerance to and/or difficulty with blood sampling through venipuncture.
- Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
- Individuals who have donated, in the days prior to first study drug administration:
- 50-499 mL of blood in the previous 30 days;
- 500 mL of blood or more in the previous 56 days.
- Donation of plasma by plasmapheresis within 7 days prior to first study drug administration.
- Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
- Use of any prescription medication within 14 days prior to first study drug administration (except for medically acceptable contraceptive products).
- Use of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements) within 14 days prior to first study drug administration (except for medically acceptable contraceptive products).
- Consumption of food or beverages containing grapefruit and/or pomelo within 10 days prior to first study drug administration.
- Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing in each study period.
- Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
- Difficulty with swallowing whole tablets or granules.
- Women who are pregnant or lactating.
- Unable or unwilling to provide informed consent.
- Have had a tattoo or body piercing within 30 days prior to first study drug administration.
- 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 22 of 51
- A participant who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized, Two-Way Crossover, Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Sachet Formulations (Desitin Arzneimittel GmbH, Germany) and Keppra 2 x 750 mg Film-Coated Tablet Formulations (UCB Pharma, Germany) in Healthy, Male and Non-Pregnant, Non-Lactating Female Volunteers Under Fasting Conditions
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.
Read the detailed description
This will be a 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, non-smoking, male and non-pregnant, non-lactating female. The products will be studied using a crossover design with 20 healthy, non-smoking, male and non-pregnant, non-lactating female volunteers being administered an oral dose of 1 × 1500 mg coated granules in sachet (Test Drug A) or 2 x 750 mg film-coated tablets (Reference Drug B) under fasting conditions.
- Being tested
- Levetiracetam 1500 mg, Keppra® 750 mg
- Keywords
- single dose, randomized, bioequivalence, two-period, crossover, levetiracetam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam 1500 mgDrug
coated granules, single oral dose
Keppra® 750 mgDrug
single oral dose of two tablets
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam 1500 mg | Experimental | Levetiracetam 1500 mg coated granules, single oral dose Receives: Drug: Levetiracetam 1500 mg |
| Keppra 750 mg | Active comparator | Keppra 750 mg film-coated tablets, single oral dose of two tablets Receives: Drug: Keppra® 750 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of clinical phase at 2 weeks
AUC
Area under Curve
Measured: From enrollment to the end of the study at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start17 Dec 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, 2-period, open-label
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desitin Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393022
- Sponsor's protocol ID
- LEV-004/K
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: internal confidential data
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, Two-Way Crossover, Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Sachet Formulations (Desitin Arzneimittel GmbH, Germany) and Keppra 2 x 750 mg Film-Coated Tablet Formulations (UCB Pharma, Germany) in Healthy, Male and Non-Pregnant, Non-Lactating Female Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT07393022
- Acronym / sponsor ID
- LEV-004/K
- Keywords
- single dose, randomized, bioequivalence, two-period, crossover, levetiracetam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Desitin Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a 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, non-smoking, male and non-pregnant, non-lactating female. The products will be studied using a crossover design with 20 healthy, non-smoking, male and non-pregnant, non-lactating female volunteers being administered an oral dose of 1 × 1500 mg coated granules in sachet (Test Drug A) or 2 x 750 mg film-coated tablets (Reference Drug B) under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, 2-period, open-label
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam 1500 mg | Experimental | Drug: Levetiracetam 1500 mgLevetiracetam 1500 mg coated granules, single oral dose |
| Keppra 750 mg | Active comparator | Drug: Keppra® 750 mgKeppra 750 mg film-coated tablets, single oral dose of two tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam 1500 mgcoated granules, single oral dose | Drug | Levetiracetam 1500 mg |
| Keppra® 750 mgsingle oral dose of two tablets | Drug | Keppra 750 mg |
Primary outcome
Bioequivalence between Levetiracetam Desitin 1500 mg coated granules and Keppra
Time frame: From enrollment to the end of clinical phase at 2 weeks
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
AUC
Time frame: From enrollment to the end of the study at 1 week
Area under Curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. internal confidential data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levetiracetam 1500 mg and Keppra® 750 mg in people with Pharmacokinetic Analysis and Bioequivalence, run by Desitin Arzneimittel GmbH at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence between Levetiracetam Desitin 1500 mg coated granules and Keppra (time frame: From enrollment to the end of clinical phase at 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.