Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine

BIAL

Status and phase: Completed; Phase 1

Conditions: Partial Epilepsy

Treatments: Drug: Eslicarbazepine acetate; Drug: Oxcarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00900237

BIA-2093-127

Details and patient eligibility

About

This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy subjects
• Aged 18-55 years
• Body mass index (18.5-29 kg/m3)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Eslicarbazepine acetate

Active Comparator group

Description:

Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9

Treatment:

Drug: Eslicarbazepine acetate

Oxcarbazepine

Active Comparator group

Description:

Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9

Treatment:

Drug: Oxcarbazepine