Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

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).
    

Intervention name(s): 50 mg BIA 9 1067; 25 mg BIA9 1067; 50 mg Ongentys; 25 mg Ongentys
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Hard Capsule; Oral; Hard Capsule; Oral; Hard Capsule; Oral; Hard Capsule; Oral
Other intervention name(s): Test IMP; Test IMP; Reference IMP; Reference IMP
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ongentys