Clinical Trial

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

Name: Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects — clinical trial record (NCT07393022)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Completed Phase 1

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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.

Trial Details

NCT Number	NCT07393022
Lead Sponsor	Desitin Arzneimittel GmbH
Conditions	Pharmacokinetic Analysis, Bioequivalence, Health Adult Subjects
Enrollment	20 participants
Start Date	2025-12-17
Primary Completion	2026-01-05 (estimated)
Study Completion	2026-01-05 (estimated)
Updated on ClinicalTrials.gov	2026-02-06