CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
BIA 2-093 - 1800 mg (Group 1) +2 moredrug
Likely dose
BIA 2-093 - 1800 mg (Group 1)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01879345
NCT01879345Phase 1Completed

A Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 in Healthy Volunteers

Bial - Portela C S.A.·interventional·Posted Jun 17, 2013·Updated Apr 8, 2025

In Brief

A Phase 1 clinical trial evaluating BIA 2-093 - 1800 mg (Group 1), BIA 2-093 - 2400 mg (Group 2), and 1 other intervention for Epilepsy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesPortugal
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 17, 2013
Enrollment StartOct 1, 2004
Primary CompletionDec 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.0 years ago

Interventions

BIA 2-093 - 1800 mg (Group 1)drug

3 tablets of BIA 2-093

BIA 2-093 - 2400 mg (Group 2)drug

4 tablets of BIA 2-093 600 mg

Placebodrug

placebo tablets