NCT07393022

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Desitin Arzneimittel GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetic Analysis
• Bioequivalence
• Health Adult Subjects

Interventions

Type	Name	Description
DRUG	Levetiracetam 1500 mg	coated granules, single oral dose
DRUG	Keppra® 750 mg	single oral dose of two tablets

Timeline

• Start date: 2025-12-17
• Primary completion: 2026-01-05
• Completion: 2026-01-05
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Canada