NCT02281591

Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine Following Oral Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single centre, open-label, randomised study in four parallel groups of healthy volunteers

Detailed description

Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093	Tablets containing 900 mg
DRUG	S-licarbazepine	capsules containing 225 mg
DRUG	R-licarbazepine	capsules containing 225 mg

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2014-11-03
• Last updated: 2025-04-08
• Results posted: 2014-12-03

Locations

1 site across 1 country: Germany