NCT04265027

Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)

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 Administrations Under Fasting Conditions in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the bioavailability and bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (50 mg and 25 mg) after single and multiple dose administration under fasting conditions in healthy volunteers and assess soluble catechol O methyltransferase (S-COMT) activity in 2 API sources of OPC at two different dosage strengths (50 mg and 25 mg) after single and multiple dose administration under fasting conditions in healthy volunteers

Detailed description

The current study aims to compare the relative bioavailability and assess the bioequivalence and tolerability of 2 different sources of opicapone from test investigational medicinal product (IMP) (BIA 9 1067) and reference IMP (Ongentys®), at doses of 25 mg and 50 mg. This was an open label, randomised, 2 period, single and multiple dose, crossover, pharmacokinetic (PK), pharmacodynamic (PD) study in 2 groups of healthy male and female subjects. The study comprised a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up. Screening (Day 28 to Day 2): Screening assessments were carried out between 28 and 2 days before first administration of investigational medicinal product (IMP). Eligible subjects were asked to return for the treatment periods. Continued eligibility was confirmed pre dose during each treatment period. Treatment Periods (Day 1 to Day 14): Eligible subjects received both of the following IMPs over 2 treatment periods (1 IMP/period). Subjects were dosed in 2 groups. Each treatment period was approximately 15 days duration, from the morning before dosing (Day 1) until the morning of Day 14. During each treatment period, subjects arrived at the Clinical Unit on Day 1. Each IMP was administered once daily on the mornings of Day 1 (single dose) and Days 3 12 (multiple dose), fasted (after an overnight fast of at least 8 hours \[h\]) with 240 mL water and subjects were discharged on the morning of Day 14 (48 h post last dose). Safety was also evaluated throughout the study. There were at least 14 days between the last dose of treatment period 1 and the first dose of treatment period 2. Post Study: Post study assessments were conducted 7 to 14 days after subjects had been discharged from their final treatment period (or if early termination occurred).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	50 mg BIA 9 1067	Hard Capsule; Oral
DRUG	25 mg BIA9 1067	Hard Capsule; Oral
DRUG	50 mg Ongentys	Hard Capsule; Oral
DRUG	25 mg Ongentys	Hard Capsule; Oral

Timeline

• Start date: 2018-02-20
• Primary completion: 2018-07-24
• Completion: 2018-07-24
• First posted: 2020-02-11
• Last updated: 2020-02-11

Locations

1 site across 1 country: United Kingdom