CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 74 enrolled
Drug / intervention
BIA 9-1067 5 mg +4 moredrug
Likely dose
BIA 9-1067 5 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/NCT02169414
NCT02169414Phase 1Completed
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Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects

Bial - Portela C S.A.·interventional·Posted Jun 23, 2014·Updated Dec 24, 2015

In Brief

A Phase 1 clinical trial evaluating BIA 9-1067 5 mg, BIA 9-1067 25 mg, and 3 other interventions for Parkinson's Disease (PD). Completed, enrolled 74 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2014
Enrollment StartFeb 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.0 years ago

Interventions

BIA 9-1067 5 mgdrug

OPC, Opicapone

BIA 9-1067 25 mgdrug

OPC, Opicapone

levodopa/carbidopa 100/25drug

immediate (standard) release levodopa/carbidopa 100/25

Placebodrug

PLC, Placebo

levodopa/benserazide 100/25 mgdrug

immediate (standard) release levodopa/benserazide