drugset
drugset / Trial / NCT02171195

A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093

NCT02171195 ↗

Phase 1 Completed 64 enrolled Bial - Portela C S.A.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.

Timeline

Start
2000-07
Primary completion
2000-10
Completion
2000-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Eslicarbazepine acetate Unknown 20 mg Oral
Subject Eslicarbazepine acetate Unknown 50 mg Oral
Subject Eslicarbazepine acetate Unknown 100 mg Oral
Subject Eslicarbazepine acetate Unknown 200 mg Oral
Subject Eslicarbazepine acetate Unknown 400 mg Oral
Subject Eslicarbazepine acetate Unknown 600 mg Oral
Subject Eslicarbazepine acetate Unknown 900 mg Oral
Subject Eslicarbazepine acetate Unknown 1200 mg Oral

Indications

epilepsy