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