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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00424671 |
This study will assess the influence of moderate hepatic impairment on the pharmacokinetics of licarbazepine after single oral administration in healthy subjects and in subjects with stable impaired hepatic function.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Licarbazepine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label Study in Healthy Subjects and in Subjects With Stable Impaired Hepatic Function to Assess the Effect of Moderate Hepatic Impairment on Licarbazepine Pharmacokinetics and Metabolism After a Single Dose of 1000 mg Licarbazepine IR Tablets |
Estimated Enrollment: | 16 |
Study Start Date: | November 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Control group and hepatically impaired groups:
Hepatically impaired group:
Control group:
Exclusion Criteria:
Control group and hepatically impaired group:
Hepatically impaired group:
Patients must be willing and able to forgo treatment with restricted medications throughout the study. Approved prescription medications will be allowed during the course of the study on a case by case basis only if the patient has been on a standard treatment regimen for at least 3 months and will continue their regular regimen without change throughout the study (unless required by protocol or to treat an adverse event) Treatments in table 5.1 are allowed in the hepatically impaired group only.
Control group
Study ID Numbers: | CLIC477D2310 |
Study First Received: | January 18, 2007 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00424671 |
Health Authority: | Czech Republic: State Institute for Drug Control |
Healthy |