Clinical trials: BIA
Epilepsy
A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.
- Trial name
- NCT02171195
- Testing
- BIA 2-093
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Partial Epilepsy
Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy
The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a…
- Trial name
- NCT00957372
- Testing
- eslicarbazepine acetate, ESL - Open-label Extension (Part II)
- Where
- Portugal
- Volunteers
- 253 people
- Sponsor
- Bial - Portela C S.A.
Pulmonary Arterial Hypertension
Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide
The purpose of this study is: To assess the effect of BIA 5 1058 400 mg on furosemide pharmacokinetics (PK). To assess the effect of furosemide 40 mg on the PK of BIA 5 1058.
- Trial name
- NCT07173738
- Testing
- BIA 5-1058, Furosemide, BIA 5-1058 and Furosemide
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Epilepsy
Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.
Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing with an oral once daily dose of 1200 mg of BIA 2-093
- Trial name
- NCT02281448
- Testing
- BIA 2-093, Contraceptives, Oral, Combined
- Where
- Portugal
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
Effect of BIA 3-202 on the Pharmacokinetics and Pharmacodynamics of Warfarin
The purpose of this study is to determine whether multiple-dose administration of nebicapone affects the pharmacokinetics of warfarin.
- Trial name
- NCT02779348
- Testing
- BIA 3-202, warfarin
- Where
- Portugal
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Pulmonary Arterial Hypertension
Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil
The purpose of this study is to assess the effect of BIA 5-1058 200 mg on the pharmacokinetic (PK) of treprostinil
- Trial name
- NCT04675944
- Testing
- BIA 5-1058, treprostinil
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Cardiovascular Diseases
Absorption, Distribution, Metabolism and Excretion of [14C] Labelled BIA 5-1058
The purpose of the study is to determine the mass balance recovery in expired air, urine and faeces after a single oral dose of 400 mg 14C-labeled BIA 5-1058; to provide plasma, urine and faecal samples for metabolite profiling…
- Trial name
- NCT04069130
- Testing
- 400 mg of BIA 5-1058
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease
Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202
The purpose of this study is to investigate the tolerability and safety of three multiple dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy volunteers.
- Trial name
- NCT02772627
- Testing
- Nebicapone
- Where
- Portugal
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson Disease
Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects
To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects
- Trial name
- NCT01520987
- Testing
- BIA 9-1067
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease
Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202
The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male…
- Trial name
- NCT02763787
- Testing
- BIA 3-202
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Epilepsy
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or…
- Trial name
- NCT02279667
- Testing
- BIA 2-093
- Where
- Portugal
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson's Disease (PD)
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/benserazide 100/25 mg…
- Trial name
- NCT02169895
- Testing
- BIA 9-1067, Prolopa®
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Kidney Diseases
Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
The aim of this clinical investigation is to prove that the seca mbca detects dialysis patients with abnormal water distribution correctly.
- Trial name
- NCT01481311
- Testing
- medical Body Composition Analyzer seca 514/515, Deuterium and Sodium Bromide dilution methods
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Seca GmbH & Co. Kg.
Parkinson's Disease
A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067
The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD)…
- Trial name
- NCT01568034
- Testing
- BIA 9-1067, Levodopa/Carbidopa, Levodopa/Benzerazide
- Where
- 3 sites in Portugal, Romania and 1 more
- Volunteers
- 10 people
- Sponsor
- Bial - Portela C S.A.
Healthy Elderly
Generation of Prediction Equations for BIA of the Elderly
The objective of the study is to develop prediction equations for calculating Fat-Free Mass FFM, Total Body Water TBW, Extracellular Water ECW, Visceral Adipose Tissue VAT, total Skeletal Muscle Mass SMM and segmental SMM in a…
- Trial name
- NCT04028648
- Where
- Germany
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Seca GmbH & Co. Kg.
Epilepsy
The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin
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.
- Trial name
- NCT02172742
- Testing
- BIA 2-093, Digoxin
- Where
- Portugal
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Pulmonary Arterial Hypertension
Effect of Food on BIA 5-1058
The aim of this study is to investigate the effect of food on the pharmacokinetic (PK) profile of BIA 5-1058 after a single dose in healthy subjects.
- Trial name
- NCT04991155
- Testing
- BIA 5-1058
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Parkinson Disease
Compassionate Use for BIA 28-6156 in Patients With Parkinson's Disease (PD) Who Have a Pathogenic Variant in the GBA1 Gene (GBA-PD) and Completed the ACTIVATE Study
This Program is designed to provide continued access BIA 28-6156, free and compassionately for an eligible patient previously enrolled in the BIA 28-6156-201 (ACTIVATE) clinical study and that had completed the study.
- Trial name
- NCT07522606
- Testing
- BIA 28-6156
- Where
- 36 sites in United States, Italy and 3 more
- Sponsor
- Bial R&D Investments, S.A.
Refractory Partial Epilepsy
Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures
This was a phase III 4-part study in multiple centres. Part I was a 26-week parallel-group, randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks double-blind titration, 12 weeks maintenance, and 4…
- Trial name
- NCT00957684
- Testing
- eslicarbazepine acetate
- Where
- Portugal
- Volunteers
- 402 people
- Sponsor
- Bial - Portela C S.A.
Epilepsy
Eslicarbazepine Acetate (BIA 2-093) as Monotherapy in Patients With Newly Diagnosed Partial-onset Seizures
This is a Phase III, multinational, open-label, non-controlled study with subjects under treatment in the double-blind BIA-2093-311 study (NCT01162460).
- Trial name
- NCT02484001
- Testing
- ESL 800 mg, ESL 1200 mg, ESL 1600 mg
- Volunteers
- 206 people
- Sponsor
- Bial - Portela C S.A.