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A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers

NCT01879332 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-12-19

Study results available
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Summary

Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose

Conditions

Interventions

DRUG

Placebo

Matching placebo tablets for oral administration

DRUG

BIA 2-093 3000 mg once daily

Eslicarbazepine acetate 600 mg tablets for oral administration

DRUG

BIA 2-093 3600 mg once daily

Eslicarbazepine acetate 600 mg tablets for oral administration

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01879332 on ClinicalTrials.gov