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

Information source: Bial - Portela C S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Partial Epilepsy

Intervention: Eslicarbazepine acetate (Drug); Oxcarbazepine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bial - Portela C S.A.

Official(s) and/or principal investigator(s):
Luc Cavens, MD, Principal Investigator, Affiliation: SGS LSS Clinical Pharmacology Unit Antwerpen

Summary

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.

Clinical Details

Official title: A Phase I, Single Centre, Open, Randomised, Parallel Study to Evaluate the Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine in Healthy Subject

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid

AUC0-t AUC From Time Zero to the Last Sampling Time

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy subjects

- Aged 18-55 years

- Body mass index (18. 5-29 kg/m3)

Locations and Contacts

SGS LSS Clinical Pharmacology Unit Antwerpen, Antwerpen B-2060, Belgium
Additional Information

Starting date: November 2008
Last updated: December 12, 2014

Page last updated: August 23, 2015

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