NCT02305030

Effect of Opicapone at Steady State on Warfarin Pharmacokinetics

Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days.

Detailed description

Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days. In Period 1, a single dose of 25 mg warfarin was administered alone. In Period 2, subjects received 475 mg OPC, on Day 1 and D2 followed by 50 mg OPC once daily for 5 days (D3 to D7). On D8, 50 mg OPC was administered with a single dose of 25 mg warfarin.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067
DRUG	Warfarin

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-12-02
• Last updated: 2014-12-02