NCT03820037

Relative Bioavailability and Bioequivalence of Opicapone

A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

the purpose assess the relative bioavailability and bioequivalence of two active pharmaceutical ingredient (API) sources of opicapone (OPC, Ongentys® and BIA 9-1067) following single 50 mg dose administration under fasting conditions in healthy volunteers

Detailed description

This will be a Phase I, open label, randomized, partial-replicate, three-period, three-sequence crossover study to investigate the relative bioavailability and bioequivalence of 2 API sources of OPC (BIA 9-1067 \[Test\] and Ongentys® \[Reference\]) in healthy adult subjects. Subjects will be randomized in a 3-period, 3-sequence crossover design; each subject will receive 2 single oral 50 mg doses of the Reference API source of OPC, and a single 50 mg dose of the Test API source of OPC under fasting conditions. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be confined to the CRU until discharge on Day 3. There will be a washout period of at least 14 days between each dose. A follow-up visit will be performed 7 to 14 days after dosing in the last treatment period or early discontinuation.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Ongentys	single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions
DRUG	BIA 9-1067 (test)	single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions

Timeline

• Start date: 2019-03-19
• Primary completion: 2019-06-09
• Completion: 2019-06-09
• First posted: 2019-01-29
• Last updated: 2020-12-31

Locations

1 site across 1 country: United Kingdom