NCT02305017

Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more.

Detailed description

Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more. In one period, subjects received three single-doses of 1 g paracetamol separated by 6 hours and 1.5 hours after the last paracetamol dose a single-dose of 50 mg OPC was administered.In the other period, a single-dose of 50 mg OPC was administered alone.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067	BIA 9-1067 50 mg
DRUG	Paracetamol	Paracetamol 1g

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-12-02
• Last updated: 2015-11-18
• Results posted: 2015-11-18