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Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

NCT01678976 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-01-08

Study results available
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Summary

To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Conditions

Interventions

DRUG

BIA 2-093

Tablets containing BIA 2-093 in doses of 300 and 600 mg

DRUG

Oxcarbazepine

Tablets containing 300 mg and 600 mg of Trileptal®

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Manuel Vaz-da-Silva, MD, PhD · BIAL - Portela & Cª S.A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2002-04-30
Completion
2002-04-30

Countries

  • Portugal

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Entities

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 NCT01678976 on ClinicalTrials.gov