Phase 1Completed
Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects
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
- Sponsor
- Desitin Arzneimittel GmbH (Industry)
- Enrolment
- 20 enrolled
- Conditions
- Pharmacokinetic Analysis; Bioequivalence; Health Adult Subjects
- Interventions
- Levetiracetam 1500 mg; Keppra® 750 mg
- Ages
- adults, older adults
- Registry
- NCT07393022
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Bioequivalence between Levetiracetam Desitin 1500 mg coated granules and Keppra
- AUC
History
Registered
Primary completion
Started