NCT03116295

Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone

A Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions in healthy male and female subjects.

Detailed description

Single-center, fasted, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-periods, two-sequence, crossover study in 2 groups of subjects. In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of OPC approved formulation \[AF\] or a single 25 mg dose of OPC formulation to be submitted for approval \[NF\]. In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of OPC (AF), or a single 50 mg dose of OPC (NF

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Opicapone (OPC)	Test treatment: 25 mg or 50 mg of OPC hard capsule (new API source NF) Reference treatment: Ongentys® 25 mg or 50 mg of OPC hard capsule (current API source - AF).

Timeline

• Start date: 2017-06-20
• Primary completion: 2017-08-28
• Completion: 2017-08-28
• First posted: 2017-04-17
• Last updated: 2018-10-15

Locations

1 site across 1 country: Germany