A 2 period study to compare 2 different formulations of Opicapone
Research type
Research Study
Full title
An Open-Label, Randomised, Two Period, Crossover-study to Assess bioavailability, bioequivalence and S-COMT activity between two Active Pharmaceutical Ingredient Sources of Opicapone at two different dosage strengths (50 mg and 25 mg) after single and multiple dose administration under fasting conditions in healthy volunteers.
IRAS ID
240123
Contact name
Annelize Koch
Contact email
Sponsor organisation
BIAL – Portela & Cª, SA
Eudract number
2017-004680-13
Duration of Study in the UK
0 years, 5 months, 20 days
Research summary
In this study subjects will be given 2 formulations of a drug called Opicapone (OPC).
The purpose of this study is to compare the test drug (BIA 9-1067) with a marketed drug called Ongentys®. Drugs containing Opicapone are given in combination with another drug called levodopa in patients suffering from Parkinson's disease.
A total of 72 healthy male and female participants are needed for this study which will consist of 2 groups. The study will be conducted at a single Phase 1 MHRA accredited unit called Simbec Research Ltd.
Participation in the trial will last for about 12 weeks (from first screening visit to final study visit). The whole trial will take about 2 and a half months to complete. The study consists of 2 groups, 2 separate treatment periods, and each of these periods will involve 15 days and 14 nights (Day-1 to Day 14) separated by a wash out period of at least 14 days between the last dose of treatment period 1 and first dose of treatment period 2.
REC name
Wales REC 1
REC reference
18/WA/0034
Date of REC Opinion
13 Feb 2018
REC opinion
Further Information Favourable Opinion