Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients
NCT02834507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2016-07-15
Summary
The purpose of this study is to determine the effect of two different multiple-dose regimens of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of levodopa in Parkinson's Disease (PD) patients.
Conditions
- Parkinson's Disease (PD)
Interventions
- DRUG
-
Matching placebo capsules
- DRUG
-
BIA 3-202
Capsules containing nebicapone 75 mg or 150 mg
- DRUG
-
Comtan®
Capsules containing entacapone 200 mg
- DRUG
-
Sinemet®
levodopa/carbidopa (Sinemet®) dose patient used to take
Sponsors & Collaborators
-
Bial - Portela C S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2005-11-30
- Completion
- 2005-11-30
More Related Trials
-
A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067
NCT01568034 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202
NCT02772627 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics
NCT03094156 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics
NCT02169414 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics
NCT02170376 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202
NCT02763787 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon
NCT01568073 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa
NCT02169479 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
NCT02763800 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients
NCT02605434 ·Status: UNKNOWN ·Phase: PHASE3
-
Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
NCT00438607 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)
NCT02763852 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients
NCT03576638 ·Status: UNKNOWN ·Phase: PHASE2
-
Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects
NCT06180720 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa
NCT02169453 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
NCT00219284 ·Status: COMPLETED ·Phase: PHASE4
-
Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in Healthy Chinese Subjects
NCT05976737 ·Status: UNKNOWN ·Phase: PHASE1
-
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide
NCT02169895 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites
NCT02772614 ·Status: COMPLETED ·Phase: PHASE1
-
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067
NCT02071810 ·Status: COMPLETED ·Phase: PHASE1
-
NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa
NCT05083260 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
NCT01171313 ·Status: COMPLETED ·Phase: PHASE2
-
Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients
NCT01568047 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide
NCT01533116 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
NCT02812394 ·Status: COMPLETED ·Phase: PHASE1