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A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers

NCT01879345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-08

Study results available
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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

Conditions

Interventions

DRUG

BIA 2-093 - 1800 mg (Group 1)

3 tablets of BIA 2-093

DRUG

BIA 2-093 - 2400 mg (Group 2)

4 tablets of BIA 2-093 600 mg

DRUG

Placebo

placebo tablets

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • Portugal

Study Locations

More Related Trials

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 NCT01879345 on ClinicalTrials.gov