NCT03116321

Bioequivalence of Two Different Sources of Eslicarbazepine Acetate

A Single Center, Single Dose, Open Label, Laboratory Blind, Randomized, Three Period, Six Sequence, Crossover Study to Determine the Bioequivalence of Two Different Sources of Eslicarbazepine Acetate (800 mg) and to Assess the Dose Equivalence of Two Different Dose Strengths of Eslicarbazepine Acetate (200 and 800 mg) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the test product, eslicarbazepine acetate 800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product, eslicarbazepine acetate 800 mg tablets (current Active pharmaceutical ingredient (API) source - Marketed formulation (MF)) (Reference, Treatment C), are bioequivalent and to demonstrate dose equivalence between eslicarbazepine acetate 4 x 200 mg tablets (test 2, TBM Treatment B) and eslicarbazepine acetate 800 mg tablet (Reference).

Detailed description

The study will comprise: * Screening period of maximum 21 days before the first administration of the investigational medicinal product (IMP); * Three treatment periods (each of which will include a profile period of 72 hours) separated by a wash out period of 7 calendar days (minimum number of days based on half-life of the analyte) to 14 calendar days (maximum number of days based on logistical arrangements) between consecutive administrations of the IMP, and * A post study visit within 1 and 2 weeks of completion of the last treatment period of the study or within 72 hours of termination or withdrawal. Subjects will be assigned randomly to treatment sequence according to randomization schedule, before the first administration of IMP. Subjects will be admitted to the study center on Day -1 and will be allowed to leave 24 hours after dosing. Subjects have to return for the subsequent blood sample collections up to 72 hours after dosing.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate (ESL)	Oral Tablet of 800 mg and 200 mg of ESL

Timeline

• Start date: 2016-12-03
• Primary completion: 2017-01-05
• Completion: 2017-01-05
• First posted: 2017-04-17
• Last updated: 2017-04-17