Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.


Clinical Trial Description

A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02169414
Study type Interventional
Source Bial - Portela C S.A.
Contact
Status Completed
Phase Phase 1
Start date February 2010
Completion date July 2010

See also
  Status Clinical Trial Phase
Completed NCT02170376 - The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics Phase 1
Completed NCT02169479 - 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 Phase 1
Completed NCT02169895 - Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide Phase 1
Completed NCT02778594 - Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide Phase 1
Completed NCT02274766 - Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia Phase 3
Completed NCT02169453 - 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 Phase 1
Completed NCT04380142 - Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease Phase 3
Withdrawn NCT06118294 - Efficacy of Probiotics for Parkinson Disease (PD) N/A
Recruiting NCT05916157 - An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease
Completed NCT03033498 - A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease Phase 1
Completed NCT02169427 - An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Phase 1
Completed NCT02834507 - 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 Phase 2
Active, not recruiting NCT04379050 - Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease Phase 3
Completed NCT02169440 - Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin Phase 1
Completed NCT02202551 - Open-Label Safety Study of ADS-5102 in PD Patients With LID Phase 3
Completed NCT01398748 - Intranasal Glutathione in Parkinson's Disease Phase 1
Recruiting NCT06107426 - Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
Completed NCT02169466 - Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide Phase 1
Recruiting NCT03732898 - Coordinated Reset Deep Brain Stimulation N/A
Completed NCT02799381 - A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER) Phase 3