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The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin

NCT02172742 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-04-06

Study results available
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Summary

The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.

Conditions

Interventions

DRUG

BIA 2-093

BIA 2-093 1200 mg once-daily

DRUG

Placebo

matching placebo

DRUG

Digoxin

Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

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
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2002-07-31
Completion
2002-07-25

Countries

  • Portugal

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 NCT02172742 on ClinicalTrials.gov