CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
BIA 9-1067 +2 moredrug
Likely dose
Madopar® HBS 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02169466
NCT02169466Phase 1Completed
CompareCT.gov

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Bial - Portela C S.A.·interventional·Posted Jun 23, 2014·Updated Nov 3, 2015

In Brief

A Phase 1 clinical trial evaluating BIA 9-1067, Placebo, and 1 other intervention for Parkinson's Disease (PD). Completed, enrolled 22 participants across 1 site.

Detailed Summary

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 controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease (PD)
CountriesPortugal
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2014
Enrollment StartJan 1, 2009
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.0 years ago

Interventions

BIA 9-1067drug

OPC, Opicapone

Placebodrug

PLC, Placebo

Madopar® HBSdrug

controlled-release levodopa 100 mg/benserazide 25 mg