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Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058

NCT04991194 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-08-05

No results posted yet for this study

Summary

the purpose of this study is to determine the effect of age on the Pharmacokinetics (PK) profile of BIA 5-1058 at steady state after multiple oral doses

Conditions

Interventions

DRUG

BIA 5-1058

Each subject was administered either 1200 mg (Part 1) or 400 mg (Part 2) BIA 5-1058 od for 10 days, in fasting conditions for 8 hours \[Day (D)2 to D9\] or 10 hours (D1 and D13), and remained fasted for 2 hours (D2 to D9) or 4 hours (D1 and D13) post-dose. The formulation was tablets 100 mg and the mode of administration was oral.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-12
Primary Completion
2016-12-30
Completion
2016-12-30

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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 NCT04991194 on ClinicalTrials.gov